A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)

NCT00988884 | Completed Phase 3 Results DMC

• 1 other identifier: V503-005
• Study Type: interventional
• Target: 1,241
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the tolerability and immunogenicity of administration of the first dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one month prior to administration of Menactra™ and Adacel™.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (7)

• Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503

  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.

  4 weeks following Month 6 vaccination

• Percentage of Participants With >=4-fold Increase in Antibody Titers to Neisseria Meningitidis Serogroups

  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.

  Baseline and 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination

• Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody

  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.

  4 weeks following Day 1 or Month 1 vaccination

• Geometric Mean Titers of Pertussis Antibody Responses

  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.

  4 weeks following Day 1 or Month 1 vaccination

• Percentage of Participants With a V503 Injection-site Adverse Experience

  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.

  Day 1 through Day 5 following Day 1 vaccination

• Percentage of Participants With a Menactra™ or Adacel™ Injection-site Adverse Experience

  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.

  Day 1 through Day 5 following Day 1 or Month 1 vaccination

• Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent)

  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.

  Up to 5 days following the Day 1 and Month 1 vaccination / visit

Secondary Outcomes (2)

• Percentage of Participants Who Seroconvert for Each of the HPV Types Contained in V503

  Month 7

• Geometric Mean Titers of the Antibody Response to Neisseria Meningitidis Serogroups Contained in Menactra™

  4 weeks following Day 1 or Month 1 vaccination

Study Arms (2)

Concomitant Vaccination

EXPERIMENTAL

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1

Biological: V503; Biological: Comparator: Menactra™ (Concomitant); Biological: Comparator: Adacel™ (Concomitant)

Non-concomitant Vaccination

EXPERIMENTAL

V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Biological: V503; Biological: Comparator: Menactra™ (Non-Concomitant); Biological: Comparator: Adacel™ (Non-concomitant)

Interventions

V503 BIOLOGICAL

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6

Concomitant Vaccination; Non-concomitant Vaccination

Comparator: Menactra™ (Concomitant) BIOLOGICAL

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.

Concomitant Vaccination

Comparator: Adacel™ (Concomitant) BIOLOGICAL

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.

Concomitant Vaccination

Comparator: Menactra™ (Non-Concomitant) BIOLOGICAL

Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Non-concomitant Vaccination

Comparator: Adacel™ (Non-concomitant) BIOLOGICAL

Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.

Non-concomitant Vaccination

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject is in good health
• Subject's parent/legal guardian can read, understand, and complete the vaccine report card
• Subject is not sexually active and does not plan on becoming sexually active during the study
• Subject has received a documented full primary immunization series against diphtheria, tetanus, and pertussis (not in the last 5 years)

You may not qualify if:

• Subject has a known allergy to any vaccine component of V503, Menactra™, or Adacel™
• Subject has a condition that is a contraindication to vaccination with Menactra™ or Adacel™
• Subject has any coagulation disorder
• Female subject is pregnant
• Subject is immunocompromised or immunodeficient
• Subject has had a splenectomy
• Subject has received immunosuppressive therapies in the prior year
• Subject has received any immune globulin product or blood-derived product in the last 3 months
• Subject has received inactivated vaccines within 14 days or live vaccines within 21 days of the first study vaccination
• Subject has received a marketed HPV vaccine or has participation in an HPV vaccine trial
• Subject has received a meningococcal vaccine
• Subject has a fever \>= 100F within 24 hours of vaccination
• Subject has a history of HPV

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (3)

• Rodrigues S, Grenha A. Activation of Macrophages: Establishing a Role for Polysaccharides in Drug Delivery Strategies Envisaging Antibacterial Therapy. Curr Pharm Des. 2015;21(33):4869-87. doi: 10.2174/1381612821666150820103910.

  PMID: 26290207 RESULT

• Schilling A, Parra MM, Gutierrez M, Restrepo J, Ucros S, Herrera T, Engel E, Huicho L, Shew M, Maansson R, Caldwell N, Luxembourg A, Ter Meulen AS. Coadministration of a 9-Valent Human Papillomavirus Vaccine With Meningococcal and Tdap Vaccines. Pediatrics. 2015 Sep;136(3):e563-72. doi: 10.1542/peds.2014-4199. Epub 2015 Aug 3.

  PMID: 26240207 RESULT

• Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15.

  PMID: 27422279 RESULT

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2009
• First Posted: October 2, 2009
• Study Start: October 21, 2009
• Primary Completion: February 22, 2011
• Study Completion: February 22, 2011
• Last Updated: December 14, 2018
• Results First Posted: January 13, 2015

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share