Trial · NCT01392378
Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
NCT01392378, Phase 4, Completed, Pfizer; results first posted 2014-02-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®. Trials, record NCT01392378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01392378
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
- NCT number
- NCT01392378
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 908 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Pneumococcal Vaccines
- Interventions
13-valent pneumococcal conjugate vaccine, INFANRIX hexa, Paracetamol, 13-valent pneumococcal conjugate vaccine, INFANRIX hexa, Ibuprofen, 13-valent pneumococcal conjugate vaccine, INFANRIX hexa, Paracetamol, 13-valent pneumococcal conjugate vaccine, INFANRIX hexa, Ibuprofen, 13-valent pneumococcal conjugate vaccine, INFANRIX hexa
- First posted
- 2011-07-12
- Last updated
- 2014-02-26
- Results first posted
- 2014-02-26
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 month after the infant series | Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
| Secondary | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 month after the infant series | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Secondary | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively. |
| Secondary | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 month after the infant series | Percentage of participants achieving serotype-specific pneumococcal OPA titer \>= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13. |
| Secondary | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 month after the infant series | Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
| Secondary | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody. |
| Secondary | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\] and pertactin \[PRN\]) antibodies. |
| Secondary | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies. |
| Secondary | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody. |
| Secondary | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 month after the infant series | Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had \>=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations. | microgram per milliliter (mcg/mL) | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. | percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | mITT toddler immunogenicity set: eligible participants who had \>=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively. | percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively. | titer | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | EU/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen. | IU/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen. | mIU/mL | GEOMETRIC_MEAN |
| SECONDARY | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | 1 month after the infant series | mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | titer | GEOMETRIC_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group625
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 4 (n = 137, 155, 148, 146, 210) | 1.64 | 95% Confidence Interval 1.44 to 1.87 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 4 (n = 137, 155, 148, 146, 210) | 1.99 | 95% Confidence Interval 1.76 to 2.25 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 4 (n = 137, 155, 148, 146, 210) | 1.48 | 95% Confidence Interval 1.31 to 1.68 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 4 (n = 137, 155, 148, 146, 210) | 2.07 | 95% Confidence Interval 1.82 to 2.34 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa | 4 (n = 137, 155, 148, 146, 210) | 2.02 | 95% Confidence Interval 1.82 to 2.25 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 6B (n = 136, 155, 148, 146, 210) | 0.68 | 95% Confidence Interval 0.55 to 0.83 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 6B (n = 136, 155, 148, 146, 210) | 0.91 | 95% Confidence Interval 0.76 to 1.10 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 6B (n = 136, 155, 148, 146, 210) | 0.56 | 95% Confidence Interval 0.46 to 0.68 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 6B (n = 136, 155, 148, 146, 210) | 0.90 | 95% Confidence Interval 0.74 to 1.09 | microgram per milliliter (mcg/mL) |
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 13vPnC + INFANRIX Hexa | 6B (n = 136, 155, 148, 146, 210) | 0.81 | 95% Confidence Interval 0.69 to 0.96 | microgram per milliliter (mcg/mL) |
1 to 10 of 625Source ClinicalTrials.gov
See all 625 results by groupParticipant flow60
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Infant Series | STARTED | 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 173 | |
| Infant Series | STARTED | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 176 | |
| Infant Series | STARTED | 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 172 | |
| Infant Series | STARTED | 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 177 | |
| Infant Series | STARTED | 13vPnC + INFANRIX Hexa | 210 | |
| Infant Series | Vaccinated Dose 1 | 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 173 | |
| Infant Series | Vaccinated Dose 1 | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 176 | |
| Infant Series | Vaccinated Dose 1 | 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 172 | |
| Infant Series | Vaccinated Dose 1 | 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | 177 | |
| Infant Series | Vaccinated Dose 1 | 13vPnC + INFANRIX Hexa | 210 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 participant flowAdverse events2,190
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series | 0 | 173 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series | 1 | 176 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series | 1 | 172 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series | 0 | 177 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC + INFANRIX Hexa - Infant Series | 0 | 210 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser | 0 | 170 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser | 0 | 174 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser | 0 | 172 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser | 0 | 176 | |
| other | Anaemia | Blood and lymphatic system disorders | 13vPnC + INFANRIX Hexa - After Infant Series | 0 | 210 |
1 to 10 of 2,190Source ClinicalTrials.gov
See all 2,190 adverse eventsAdverse event totals45
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series | ||
| Total, all-cause mortality | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series | ||
| Total, all-cause mortality | 13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series | ||
| Total, all-cause mortality | 13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series | ||
| Total, all-cause mortality | 13vPnC + INFANRIX Hexa - Infant Series | ||
| Total, all-cause mortality | 13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser | ||
| Total, all-cause mortality | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser | ||
| Total, all-cause mortality | 13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser | ||
| Total, all-cause mortality | 13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser | ||
| Total, all-cause mortality | 13vPnC + INFANRIX Hexa - After Infant Series |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28262330 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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