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 - Tabular View

Tracking Information

First Received Date ^ICMJE

April 7, 2006

Last Updated Date

June 12, 2009

Start Date ^ICMJE

April 2006

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Antibody Response to Hepatitis A - Participants With a Serological Response [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ] [ Designated as safety issue: No ]
Antibody Response to Varicella - Participants With a Serological Response [ Time Frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Participants With 1 or More Systemic Adverse Experience [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
Participants With 1 or More Systemic Adverse Experience [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
Participants With 1 or More Systemic Adverse Experience. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Participants With 1 or More Injection-Site Adverse Experience [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
Participants With 1 or More Injection-Site Adverse Experience [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
Participants With 1 or More Injection-Site Adverse Experience [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
Participants With Elevated Temperature (≥102.2F/ ≥39.0C) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Participants With 1 or More Serious Vaccine-Related Adverse Experience [ Time Frame: 6 weeks post dose 1 ] [ Designated as safety issue: Yes ]
Participants With 1 or More Serious Vaccine-Related Adverse Experience [ Time Frame: 4 weeks post dose 2 ] [ Designated as safety issue: Yes ]
Participants With 1 or More Serious Vaccine-Related Adverse Experience [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Antibody Response to Hepatitis A - Geometric Mean Titer [ Time Frame: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™) ] [ Designated as safety issue: No ]
Antibody Response to Varicella - Geometric Mean Titer [ Time Frame: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]
Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer [ Time Frame: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Antibody responses to Hepatitis A (4 weeks Post dose 2), Varicella (6 weeks Post dose 1), and S. Pneumoniae (6 weeks Postvaccination). Safety profile of concomitant use of Hepatitis A vaccine with other study vaccines.

Change History

Complete list of historical versions of study NCT00312858 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Open, Randmzd., Multictr Study of the Safety, Tolerability, & Immunogenicity of Hepatitis A Vaccine, Inactivated Given Concomitantly With Measles, Mumps, Rubella, & Varicella [Oka/Merck] Virus Vaccine Live & Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197 Protein) in Healthy 12-Month-Olds

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.

Detailed 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Hepatitis A Virus

Intervention ^ICMJE

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

Study Arms / Comparison Groups

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.
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.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

653

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

12 Months to 15 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00312858

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2005_075, V251-067

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP