A Study of V503 Vaccine Given Concomitantly With REPEVAX™ in 11 to 15 Year Olds (V503-007)

NCT01073293 | Completed Phase 3 Results DMC

• 2 other identifiers: V503-0072010_512
• Study Type: interventional
• Target: 1,054
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate whether co-administration of the first dose of V503 and REPEVAX™ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAX™ one month following the first dose of V503.

Conditions

Papillomavirus Infections

Outcome Measures

Primary Outcomes (8)

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

  Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL.

  4 weeks following Month 6 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 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 Repevax™ Injection-site Adverse Experience

  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. 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 vaccine is also an AE. Only injection-site AEs in the arm that received Repevax™ vaccination were reported for this endpoint.

  Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) 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

• Percentage of Participants With a Systemic Adverse Experience

  For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is 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 vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site.

  Up to 15 days following the Day 1 and Month 1 vaccination / visit

• 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. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of \>=0.1 IU/mL.

  4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) 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. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL).

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

• Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus 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 poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at \>=1:8 dilution of serum.

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

Secondary Outcomes (1)

• Percentage of Participants Who Seroconvert for Each of the HPV Types

  Month 7

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

Biological: V503 Vaccine; Biological: REPEVAX™ (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 Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1

Biological: V503 Vaccine; Biological: REPEVAX™ (Non-concomitant)

Interventions

V503 Vaccine BIOLOGICAL

V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6

Concomitant Vaccination; Non-concomitant Vaccination

REPEVAX™ (Concomitant) BIOLOGICAL

REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1

Concomitant Vaccination

REPEVAX™ (Non-concomitant) BIOLOGICAL

REPEVAX™ given as a single 0.5 mL intramuscular injection 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:

• Participant is in good health
• Participant's parent/legal guardian can read, understand, and complete the vaccination report card
• Participant is not sexually active and does not plan on becoming sexually active during the study
• Participant has received a documented full primary immunization series against diphtheria, tetanus, pertussis, and poliovirus (inactivated and/or oral poliovirus), but not in the last 5 years. There must be a 5-year interval from a prior vaccination containing any one of these vaccine antigens.

You may not qualify if:

• Participant has a known allergy to any vaccine component of V503 or REPEVAX™
• Participant has had a severe reaction affecting the brain (e.g., evolving encephalopathy) within 7 days after a previous dose of a pertussis-containing vaccine
• Participant has had a progressive severe illness affecting the brain after a previous dose of tetanus, diphtheria, poliovirus or a component pertussis combination (acellular and whole cell) vaccine
• Participant ever had Guillain-Barré syndrome or brachial neuritis following a previous dose of a tetanus-containing vaccine
• Participant has a condition that is a contraindication to vaccination as indicated in the most up to date package inserts of REPEVAX™
• Participant has a history of severe allergic reaction that required medical intervention
• Participant has hemophilia, thrombocytopenia, is receiving anticoagulation therapy and/or has any coagulation disorder that would contraindicate intramuscular injections
• Participant is concurrently enrolled in clinical studies of investigational agents
• Female participant is pregnant
• Participant has donated blood within 1 week prior to first study vaccination, or intends to donate during the study
• Participant is immunocompromised, immunodeficient, or has an autoimmune condition
• Participant has had a splenectomy
• Participant has received immunosuppressive therapies in the prior year
• Participant has received immune globulin product or blood-derived product in the last 3 months
• Participant has received inactivated vaccine(s) within 14 days or live vaccine(s) within 21 days of first study vaccination

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (2)

• Kosalaraksa P, Mehlsen J, Vesikari T, Forsten A, Helm K, Van Damme P, Joura EA, Ciprero K, Maansson R, Luxembourg A, Sobanjo-ter Meulen A. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Pediatr Infect Dis J. 2015 Jun;34(6):627-34. doi: 10.1097/INF.0000000000000694.

  PMID: 25831420 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 Director

  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: February 19, 2010
• First Posted: February 23, 2010
• Study Start: April 22, 2010
• Primary Completion: June 16, 2011
• Study Completion: June 16, 2011
• Last Updated: November 27, 2018
• Results First Posted: December 22, 2014

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share