Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)

Brief Summary

Official Title: “An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of VAQTA™ Given Concomitantly With PedvaxHIB™ and Infanrix™ in Healthy Children 15 Months of Age”

This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: June 2010

Detailed Clinical Trial Description

In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated.

In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was collected after each dose.

Interventions Used in this Clinical Trial

  • Biological: Comparator: VAQTA™
    • VAQTA™ (Hepatitis A Vaccine, Inactivated). Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.
  • Biological: Comparator: Infanrix™
    • Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline). One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.
  • Biological: Comparator: PedvaxHIB™
    • PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]). One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)
    • Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
  • Experimental: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)
    • Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
  • Experimental: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)
    • Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
  • Experimental: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)
    • Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
  • Experimental: VAQTA™/VAQTA™ (Stage 2)
    • Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered.

Outcome Measures for this Clinical Trial

Primary Measures

  • Seropositivity Rate (SPR) to Hepatitis A
    • Time Frame: 4 weeks after dose 2 of VAQTA™
      Safety Issue?: No
  • Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
    • Time Frame: 4 weeks postvaccination with PedvaxHIB™
      Safety Issue?: No
  • Number of Participants With Adverse Events (AE)
    • Time Frame: Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs
      Safety Issue?: Yes
  • Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
    • Time Frame: 4 weeks postvaccination with Infanrix™
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases
  • Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A

Exclusion Criteria

  • Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder
  • Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Months

Maximum Age for this Clinical Trial: 17 Months

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

Citations Reporting on Results

Petrecz M, Ramsey KP, Stek JE, Martin JC, Klopfer SO, Kuter B, Schödel FP, Lee AW. Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children. Hum Vaccin Immunother. 2016;12(2):503-11. doi: 10.1080/21645515.2015.1080395.

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00289913