Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)

NCT00312858 | Completed Phase 4 Results

• 2 other identifiers: V251-0672005_075
• Study Type: interventional
• Target: 653
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella \[Oka/Merck\] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.

Conditions

Hepatitis A Virus

Keywords

Hepatitis A Virus

Outcome Measures

Primary Outcomes (15)

• Antibody Response to Hepatitis A - Participants With a Serological Response

  Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus

  4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)

• Antibody Response to Varicella - Participants With a Serological Response

  Participants with varicella baseline antibody titer \<1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)

  6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)

• Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers

  Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay

  6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)

• Participants With 1 or More Systemic Adverse Experience

  Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.

  6 weeks post dose 1

• Participants With 1 or More Systemic Adverse Experience

  Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.

  4 weeks post dose 2

• Participants With 1 or More Systemic Adverse Experience.

  Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart

  6 months

• Participants With 1 or More Injection-site Adverse Experience

  Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.

  6 weeks post dose 1

• Participants With 1 or More Injection-site Adverse Experience

  Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.

  4 weeks post dose 2

• Participants With 1 or More Injection-site Adverse Experience

  Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.

  6 months

• Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

  Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.

  6 weeks post dose 1

• Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

  Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.

  4 weeks post dose 2

• Participants With Elevated Temperature (≥102.2F/ ≥39.0C)

  Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.

  6 months

• Participants With 1 or More Serious Vaccine-related Adverse Experience

  Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine

  6 weeks post dose 1

• Participants With 1 or More Serious Vaccine-related Adverse Experience

  Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine

  4 weeks post dose 2

• Participants With 1 or More Serious Vaccine-related Adverse Experience

  Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine

  6 months

Other Outcomes (9)

• Antibody Response to Hepatitis A - Geometric Mean Titer

  4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)

• Antibody Response to Varicella - Geometric Mean Titer

  6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)

• Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response

  6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)

Study Arms (2)

1

ACTIVE COMPARATOR

Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.

Biological: Comparator: VAQTA™ (Hepatitis A vaccine); Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

2

ACTIVE COMPARATOR

Arm 2: ProQuad™ 0.5 mL injection (2 doses \~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.

Biological: Comparator: VAQTA™ (Hepatitis A vaccine); Biological: Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine); Biological: Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)

Interventions

Comparator: VAQTA™ (Hepatitis A vaccine) BIOLOGICAL

VAQTA™ 0.5 mL injection

1; 2

Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) BIOLOGICAL

ProQuad™ 0.5 mL injection

1; 2

Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine) BIOLOGICAL

Prevnar™ 0.5 mL injection

1; 2

Eligibility Criteria

• Age: 12 Months - 15 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 15-month-old males and females with no active liver disease
• A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster

You may not qualify if:

• Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
• Any immune deficiency
• History of allergy to any of the vaccine components
• History of any seizure disorder

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schodel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.

  PMID: 23744509 DERIVED

MeSH Terms

Conditions

Hepatitis

Interventions

Hepatitis A Vaccines; Chickenpox Vaccine; Pneumococcal Vaccines

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Herpesvirus Vaccines; Streptococcal Vaccines; Bacterial Vaccines

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2006
• First Posted: April 11, 2006
• Study Start: April 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 13, 2017
• Results First Posted: August 3, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share