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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 4

Conditions: Hepatitis A Virus

Treatments: Biological: Comparator: PedvaxHIB™; Biological: Comparator: Infanrix™; Biological: Comparator: VAQTA™

Study type: Interventional

Funder types: Industry

Identifiers

NCT00289913

2005_076

V251-068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,274 patients

Sex: All

Ages: 12 to 17 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,274 participants in 5 patient groups

VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)

Experimental group

Description:

Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.

Treatment:

Biological: Comparator: Infanrix™

Biological: Comparator: PedvaxHIB™

Biological: Comparator: VAQTA™

PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)

Experimental group

Description:

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.

Treatment:

Biological: Comparator: Infanrix™

Biological: Comparator: PedvaxHIB™

Biological: Comparator: VAQTA™

VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)

Experimental group

Description:

Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.

Treatment:

Biological: Comparator: PedvaxHIB™

Biological: Comparator: VAQTA™

PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)

Experimental group

Description:

Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.

Treatment:

Biological: Comparator: PedvaxHIB™

Biological: Comparator: VAQTA™

VAQTA™/VAQTA™ (Stage 2)

Experimental group

Description:

Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered.

Treatment:

Biological: Comparator: VAQTA™