Phase 4 N=653 Randomized Prevention

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)

Hepatitis A Virus

Bottom Line

View on ClinicalTrials.gov: NCT00312858 ↗

Enrolled (actual)

653

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Antibody Response to Hepatitis A - Participants With a Serological Response — 182; 158 Participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Comparator: VAQTA™ (Hepatitis A vaccine) (Biological); Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) (Biological); Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine) (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Mar 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Antibody Response to Hepatitis A - Participants With a Serological Response	182; 158	<0.001 sig
PRIMARY Antibody Response to Varicella - Participants With a Serological Response	222; 231; 210; 228	0.013 sig
PRIMARY Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers	1.8; 1.6; 9.5; 9.6; 3.7; 4.1	<0.001 sig
PRIMARY Participants With 1 or More Systemic Adverse Experience	88; 77	—
PRIMARY Participants With 1 or More Systemic Adverse Experience	88; 77	—
PRIMARY Participants With 1 or More Systemic Adverse Experience.	204; 133	—
PRIMARY Participants With 1 or More Injection-site Adverse Experience	105; 95	—
PRIMARY Participants With 1 or More Injection-site Adverse Experience	105; 95	—
PRIMARY Participants With 1 or More Injection-site Adverse Experience	105; 95	—
PRIMARY Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	16; 10	—
PRIMARY Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	16; 10	—
PRIMARY Participants With Elevated Temperature (≥102.2F/ ≥39.0C)	16; 10	—
PRIMARY Participants With 1 or More Serious Vaccine-related Adverse Experience	0; 1	—
PRIMARY Participants With 1 or More Serious Vaccine-related Adverse Experience	0; 1	—
PRIMARY Participants With 1 or More Serious Vaccine-related Adverse Experience	0; 1	—

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.

Eligibility Criteria

Inclusion Criteria

12- 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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00312858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.