Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Rubella; Diphtheria; Haemophilus Infections; Hepatitis B; Pertussis; Tetanus; Varicella; Mumps; Measles

Treatments: Biological: ProQuad®; Biological: Infanrix® hexa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432042

X06-MMRV-302 (Other Identifier)

V221-035

2006-004129-27 (EudraCT Number)

Details and patient eligibility

About

Primary Objective:

• To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing either the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b; or to the 3 pertussis antibody titres measured at 42 days following vaccination.

Secondary Objectives:

• To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination by an Infanrix® hexa primary series schedule and all data are pooled.
• To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa by an Infanrix® hexa primary series schedule and all data are pooled.

Enrollment: 955 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy participants of either gender
• Aged 12 to 23 months
• No clinical history of measles, mumps, rubella, varicella and zoster
• For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion
• For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion
• Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study
• Parent(s)/legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion criteria

• Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination
• Any recent (<= 30 days) exposure to measles, mumps, rubella, varicella and/or zoster
• Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa
• Any recent (<= 3 days) history of febrile illness
• Any severe chronic disease
• Active untreated tuberculosis
• Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
• Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems
• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
• Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin
• Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity
• Any recent (<= 2 days) tuberculin test or scheduled tuberculin test through Visit 2
• Any previous (<= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2
• Any recent (<= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2
• Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
• Any recent (≤30 days) participation or scheduled participation in any other clinical trial through Visit 2

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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955 participants in 3 patient groups

ProQuad® + Infanrix® hexa

Experimental group

Description:

Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Treatment:

Biological: ProQuad®

Biological: Infanrix® hexa

ProQuad®

Active Comparator group

Description:

Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Treatment:

Biological: ProQuad®

Infanrix® hexa

Active Comparator group

Description:

Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).

Treatment:

Biological: Infanrix® hexa