Trial · NCT00988884
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
NCT00988884, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2015-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005). Trials, record NCT00988884. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00988884
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
- NCT number
- NCT00988884
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,241 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Human Papillomavirus Infection
- Interventions
- V503, Comparator: Menactra™ (Concomitant), Comparator: Adacel™ (Concomitant), Comparator: Menactra™ (Non-Concomitant), Comparator: Adacel™ (Non-concomitant)
- First posted
- 2009-10-02
- Last updated
- 2018-12-14
- Results first posted
- 2015-01-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | 4 weeks following Month 6 vaccination | Serum antibody titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were evaluated using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL. |
| Primary | Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups | Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination | For the Concomitant Vaccination group, serum samples were collected at Day 1 (baseline) and 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected at Month 1 (baseline) and 4 weeks after the Month 1 vaccination. Bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The serum bactericidal titer is reported as the reciprocal of the final serum dilution giving \>50% killing in 60 minutes. |
| Primary | Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | 4 weeks following Day 1 or Month 1 vaccination | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. The lower limit of quantitation of the assay was defined as 0.01 International Units (IU)/mL. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limit of quantitation of the assay was defined as 0.04 IU/mL. Acceptable titers refer to the World Health Organization-defined protective titers of \>=0.1 IU/mL. |
| Primary | Geometric Mean Titers of Pertussis Antibody Responses | 4 weeks following Day 1 or Month 1 vaccination | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. The titers were expressed as Enzyme-linked Immunoassay Units (ELU)/mL. |
| Primary | Percentage of Participants With a V503 Injection-site Adverse Experience | Day 1 through Day 5 following Day 1 vaccination | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint. |
| Primary | Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience | Day 1 through Day 5 following Day 1 or Month 1 vaccination | An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Only injection-site AEs in the arm that received Menactra™ and Adacel™ vaccination were reported for this endpoint. For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. |
| Primary | Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) | Up to 5 days following the Day 1 and Month 1 vaccination / visit | For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination. |
| Secondary | Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 | Month 7 | Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: \>=30, HPV Type 11: \>=16; HPV Type 16: \>=20, HPV Type 18: \>=24, HPV Type 31: \>=10, HPV Type 33: \>=8, HPV Type 45: \>=8, HPV Type 52: \>=8, and HPV Type 58: \>=8. |
| Secondary | Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™ | 4 weeks following Day 1 or Month 1 vaccination | Serum bactericidal antibodies to Neisseria meningitidis serogroups A, C, Y, and W-135 were measured by incubating serial dilutions of serum with target N. meningitidis strains and complement, and enumerating the surviving bacteria after overnight incubation on blood agar plates. The antibody titer is expressed as the reciprocal of the highest dilution that achieves \>50% bacterial killing; a higher value represents a greater antibody response. For the Concomitant Vaccination group, serum samples were collected 4 weeks after Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after Month 1 vaccination. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | 4 weeks following Month 6 vaccination | The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint | milli Merck Units/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups | Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination | The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | 4 weeks following Day 1 or Month 1 vaccination | The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint | Percentage of participants | NUMBER |
| PRIMARY | Geometric Mean Titers of Pertussis Antibody Responses | 4 weeks following Day 1 or Month 1 vaccination | The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint | ELU/mL | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants With a V503 Injection-site Adverse Experience | Day 1 through Day 5 following Day 1 vaccination | The population analyzed included all vaccinated participants with follow-up for injection-site AEs | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience | Day 1 through Day 5 following Day 1 or Month 1 vaccination | The population analyzed included all vaccinated participants with follow-up for injection-site AEs | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) | Up to 5 days following the Day 1 and Month 1 vaccination / visit | The population analyzed included all vaccinated participants with follow-up | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503 | Month 7 | The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint | Percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™ | 4 weeks following Day 1 or Month 1 vaccination | The per-protocol population included participants who received study vaccination and had serum samples available for evaluation of the endpoint | Titer | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group70
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Concomitant Vaccination | Anti-HPV 6: n=501, 514 | 2198.7 | Full Range 137.0 to 18555.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Non-concomitant Vaccination | Anti-HPV 6: n=501, 514 | 2260.7 | Full Range 210.0 to 30594.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Concomitant Vaccination | Anti-HPV 11: n=502, 514 | 1495.0 | Full Range 64.0 to 13292.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Non-concomitant Vaccination | Anti-HPV 11: n=502, 514 | 1547.2 | Full Range 109.0 to 30345.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Concomitant Vaccination | Anti-HPV 16: n=513, 530 | 8882.6 | Full Range 159.0 to 60653.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Non-concomitant Vaccination | Anti-HPV 16: n=513, 530 | 9027.6 | Full Range 619.0 to 125497.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Concomitant Vaccination | Anti-HPV 18: n=516, 535 | 2610.4 | Full Range 35.0 to 49077.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Non-concomitant Vaccination | Anti-HPV 18: n=516, 535 | 2633.9 | Full Range 79.0 to 45639.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Concomitant Vaccination | Anti-HPV 31: n=514, 536 | 2439.4 | Full Range 50.0 to 43734.0 | milli Merck Units/mL |
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Non-concomitant Vaccination | Anti-HPV 31: n=514, 536 | 2334.3 | Full Range 89.0 to 45636.0 | milli Merck Units/mL |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Concomitant Vaccination | 621 | |
| Overall Study | STARTED | Non-concomitant Vaccination | 620 | |
| Overall Study | COMPLETED | Concomitant Vaccination | 586 | |
| Overall Study | COMPLETED | Non-concomitant Vaccination | 584 | |
| Overall Study | NOT COMPLETED | Concomitant Vaccination | 35 | |
| Overall Study | NOT COMPLETED | Non-concomitant Vaccination | 36 |
Source ClinicalTrials.gov
Adverse events32
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 | Injection-site erythema | General disorders | Concomitant Vaccination | 245 | 613 | 385 |
| other | Injection-site erythema | General disorders | Non-concomitant Vaccination | 233 | 611 | 357 |
| other | Injection-site pain | General disorders | Concomitant Vaccination | 518 | 613 | 1,373 |
| other | Injection-site pain | General disorders | Non-concomitant Vaccination | 490 | 611 | 1,298 |
| other | Injection-site swelling | General disorders | Concomitant Vaccination | 276 | 613 | 492 |
| other | Injection-site swelling | General disorders | Non-concomitant Vaccination | 255 | 611 | 414 |
| other | Pyrexia | General disorders | Concomitant Vaccination | 88 | 613 | 111 |
| other | Pyrexia | General disorders | Non-concomitant Vaccination | 95 | 611 | 113 |
| other | Nasopharyngitis | Infections and infestations | Concomitant Vaccination | 32 | 613 | 36 |
| other | Nasopharyngitis | Infections and infestations | Non-concomitant Vaccination | 27 | 611 | 30 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Concomitant Vaccination | ||
| Total, all-cause mortality | Non-concomitant Vaccination | ||
| Total, other adverse events | Concomitant Vaccination | 543 | 613 |
| Total, other adverse events | Non-concomitant Vaccination | 518 | 611 |
| Total, serious adverse events | Concomitant Vaccination | 5 | 613 |
| Total, serious adverse events | Non-concomitant Vaccination | 5 | 611 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Concomitant Vaccination vs Non-concomitant Vaccination: serious adverse events |
Source 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.
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