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 Clinical Trial

Official title:

An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312858
• Other study ID #: V251-067
• Secondary ID: 2005_075
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2006
• Last updated: October 29, 2015
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.

Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 653
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 15 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis A Virus

Intervention

Biological:
• Comparator: VAQTA™ (Hepatitis A vaccine)
VAQTA™ 0.5 mL injection
• Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
ProQuad™ 0.5 mL injection
• Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Prevnar™ 0.5 mL injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibody Response to Hepatitis A - Geometric Mean Titer	Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus	4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)	No
Other	Antibody Response to Varicella - Geometric Mean Titer	Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL	6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)	No
Other	Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response	Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	No
Other	Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response	Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	No
Other	Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response	Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	No
Other	Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response	Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	No
Other	Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response	Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	No
Other	Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response	Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	No
Other	Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response	Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F	6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)	No
Primary	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™)	No
Primary	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™)	No
Primary	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™)	No
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes

External Links

•   MedWatch - FDA maintained medical product safety Information
•   Merck: Patient & Caregiver U.S. Product Web Site