Trial · NCT02853929
Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
NCT02853929, Phase 4, Completed, GlaxoSmithKline; results first posted 2020-01-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery. Trials, record NCT02853929. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02853929
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
- NCT number
- NCT02853929
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 551 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Diphtheria, Hepatitis B, Acellular Pertussis, Haemophilus Influenzae Type b, Tetanus, Poliomyelitis, Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
- Interventions
- Infanrix hexa
- First posted
- 2016-08-03
- Last updated
- 2020-01-14
- Other registries' IDs
- eudract:2014-001120-30
- Results first posted
- 2020-01-14
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | At one month after the booster dose (Day 30) | Seroprotected subjects were defined as subjects with antibody concentrations/titres above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 International units per milliliter (IU/ml) for anti-D and anti-T, 10 milli-International units per milliliter (mIU/mL) for anti-HB's, 8 Effective Dose 50 (ED50) for anti-polio virus (type 1,2,3) and 0.15 microgram/milliliter (µg/mL) for anti-PRP were considered as immunological correlates of protection. |
| Primary | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | At one month after the booster dose (Day 30) | Booster response to PT, FHA and PRN antigens was defined as: * for subjects with pre-vaccination antibody concentration below the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off, * for subjects with pre-vaccination antibody concentration between the assay cut-off and below 4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration, and * for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration Seronegative (S-) subjects are those who have antibody concentration less than (\<) assay cut-off. Seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN |
| Secondary | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Before the booster dose (Day 0) | Seroprotected subjects were defined as subjects with antibody concentrations/titers above or equal (≥) the assay cut-offs that are accepted immunological correlates of protection. 0.1 IU/mL for anti-D and anti-T, 10 mIU/mL for anti-HB's, 8 ED50 for anti-polio virus (type 1,2,3) and 0.15 µg/mL for anti-PRP were considered as immunological correlates of protection. |
| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Before the booster dose (Day 0) | Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN |
| Secondary | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Before the booster dose (Day 0) | Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off's for anti-pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) are 0.080 µg/mL, 0.075 µg/mL, 0.061 µg/mL, 0.198 µg/mL, 0.111 µg/mL, 0.102 µg/mL, 0.063 µg/mL, 0.66 µg/mL, 0.160 µg/mL, 0.111 µg/mL, 0.199 µg/mL, 0.163 µg/mL, 0.073 µg/mL respectively. |
| Secondary | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in IU/mL. |
| Secondary | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Anti-Poliovirus type 1, 2 and 3 antibody titers were expressed as Geometric Mean Titers (GMT). |
| Secondary | Anti-HBs Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in mIU/mL. |
| Secondary | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in µg/mL. |
| Secondary | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | At one month after the booster dose (Day 30) | Seropositive subjects were defined as subjects whose antibody concentration/titre was greater than or equal to the assay cut-off. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti- FHA and 2.187 IU/mL for anti-PRN |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | At one month after the booster dose (Day 30) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With a Booster Response to Pertussis Antigens (Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)) | At one month after the booster dose (Day 30) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seroprotected Subjects Against Anti-diphtheria, Anti-tetanus, Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3, Anti-HBs and Anti-PRP. | Before the booster dose (Day 0) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN | Before the booster dose (Day 0) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Seropositive Subjects for Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) | Before the booster dose (Day 0) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before vaccination. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Anti-D, Anti-T, Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination. | IU/ml | GEOMETRIC_MEAN |
| SECONDARY | Anti-poliovirus Type 1, 2, 3 Antibody Titres | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Anti-HBs Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination. | mIU/mL | GEOMETRIC_MEAN |
| SECONDARY | Anti-pneumococcal Serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) and Anti-PRP Antibody Concentrations | Before the booster dose (Day 0) and One month after the booster dose (Day 30) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, before and after vaccination. | µg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN. | At one month after the booster dose (Day 30) | Analysis was performed on the According to Protocol (ATP) cohort for immunogenicity, which included all subjects who met eligibility criteria, received the booster dose of the study vaccines and for whom assay results were available for antibodies against at least one study vaccine antigen component, after vaccination. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group248
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | dTpa Group | Anti-D | 221 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Control Group | Anti-D | 247 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | dTpa Group | Anti-T | 221 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Control Group | Anti-T | 247 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | dTpa Group | Anti-HBs | 215 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Control Group | Anti-HBs | 239 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | dTpa Group | Anti-polio 1 | 204 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Control Group | Anti-polio 1 | 228 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | dTpa Group | Anti-polio 2 | 201 | Participants | |
Number of Seroprotected Subjects Against Anti-diphtheria (Anti-D), Anti-tetanus (Anti-T), Anti-hepatitis B (Anti-HBs), Anti-poliovirus Type 1, Anti-poliovirus Type 2, Anti-poliovirus Type 3 and Anti-polyribosyl-ribitol Phosphate (Anti-PRP) | Control Group | Anti-polio 2 | 227 | Participants |
1 to 10 of 248Source ClinicalTrials.gov
See all 248 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | dTpa Group | 270 | |
| Overall Study | STARTED | Control Group | 281 | |
| Overall Study | Vaccinated | dTpa Group | 263 | |
| Overall Study | Vaccinated | Control Group | 277 | |
| Overall Study | COMPLETED | dTpa Group | 259 | |
| Overall Study | COMPLETED | Control Group | 277 | |
| Overall Study | NOT COMPLETED | dTpa Group | 11 | |
| Overall Study | NOT COMPLETED | Control Group | 4 |
Source ClinicalTrials.gov
Adverse events204
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 | Hydrocele | Congenital, familial and genetic disorders | dTpa Group | 0 | 263 | 0 |
| other | Hydrocele | Congenital, familial and genetic disorders | Control Group | 1 | 277 | 1 |
| other | Phimosis | Congenital, familial and genetic disorders | dTpa Group | 1 | 263 | 1 |
| other | Phimosis | Congenital, familial and genetic disorders | Control Group | 0 | 277 | 0 |
| other | Ear pain | Ear and labyrinth disorders | dTpa Group | 0 | 263 | 0 |
| other | Ear pain | Ear and labyrinth disorders | Control Group | 1 | 277 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | dTpa Group | 0 | 263 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Control Group | 1 | 277 | 1 |
| other | Anal fissure | Gastrointestinal disorders | dTpa Group | 1 | 263 | 1 |
| other | Anal fissure | Gastrointestinal disorders | Control Group | 0 | 277 | 0 |
1 to 10 of 204Source ClinicalTrials.gov
See all 204 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | dTpa Group | 0 | 263 |
| Total, all-cause mortality | Control Group | 0 | 277 |
| Total, other adverse events | dTpa Group | 232 | 263 |
| Total, other adverse events | Control Group | 257 | 277 |
| Total, serious adverse events | dTpa Group | 0 | 263 |
| Total, serious adverse events | Control Group | 3 | 277 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33612341 | 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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| dTpa Group vs Control Group: Number of Subjects With Unsolicited Adverse Events (AEs) | Trial comparisons |
| dTpa Group vs Control Group: Number of Subjects With Serious Adverse Events (SAEs) | Trial comparisons |
| dTpa Group vs Control Group: deaths from any cause | Trial comparisons |
| dTpa Group vs Control Group: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02853929
GET https://conductscience.org/api/trials/v1/NCT02853929/results?page=2