Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Tetanus; Acellular Pertussis

Treatments: Biological: SB213503 lot 3; Biological: IPOL; Biological: Infanrix; Biological: SB213503 lot 1; Biological: SB213503 lot 2; Biological: M-M-R II

Study type: Interventional

Funder types: Industry

Identifiers

NCT00148941

213503/048

Details and patient eligibility

About

The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.

Full description

• Investigational groups: 3, each receive one of 3 lots of DTaP-IPV vaccine.
• Control: US-licensed DTaP (Infanrix) + US-licensed IPV (IPOL) vaccines administered in separate injections.
• Two study visits one month apart for a subset of subjects (Safety and Immunogenicity subset) with a blood draw at each visit. All other subjects will have one visit.
• A telephone contact 4-6 days after vaccination for all subjects, a telephone contact 31-38 days after vaccination for the Safety only subset and a telephone contact for all subjects during the extended safety follow-up phase (5 months following the active phase).

Enrollment: 4,209 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female child between and including 4 and 6 years of age at the time of vaccination.
• Free of obvious health problems as established by medical history and brief medical evaluation before entering into the study.
• Received 4 doses of Infanrix and 3 doses of IPOL during the first 2 years of life.
• Vaccination against measles, mumps, and rubella in the second year of life.
• Subjects whom the investigator believed would comply with the requirements of the protocol.
• Written informed consent obtained before study entry from the parent(s) or guardian(s) of the subject.

Exclusion criteria

• Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
• History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, or rubella disease, or of vaccination against these diseases given after the second year of life.
• Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.
• Poliovirus vaccination with one or more doses of OPV vaccine.
• Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
• Chronic administration or administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30.
• Administration of immunoglobulins and/or any blood products within three months prior to study vaccination or planned administration during the study period ending at Day 30.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
• History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrollment.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including allergic reactions to 2-phenoxyethanol, formaldehyde, neomycin, polymyxin B, streptomycin, gelatin, and/or latex.
• History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).
• Encephalopathy within 7 days of administration of previous dose of Infanrix.
• Fever ≥ 40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary) within 48 hours of previous dose of Infanrix not due to another identifiable cause.
• Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of previous dose of Infanrix.
• Persistent, severe, inconsolable screaming or crying lasting ≥ 3 hours which occurred within 48 hours of administration of previous dose of Infanrix.
• Thrombocytopenia following a previous dose of M-M-RII or its component vaccines.
• Inability to contact a parent/guardian of the subject by telephone.
• Blood dyscrasias (including current thrombocytopenia), leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems.
• Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject was demonstrated.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,209 participants in 4 patient groups

SB213503 lot 1 + M-M-R Group

Experimental group

Description:

Subjects aged 4 to 6 years received a dose of lot 1 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Treatment:

Biological: M-M-R II

Biological: SB213503 lot 1

SB213503 lot 2 + M-M-R Group

Experimental group

Description:

Subjects aged 4 to 6 years received a dose of lot 2 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Treatment:

Biological: M-M-R II

Biological: SB213503 lot 2

SB213503 lot 3 + M-M-R Group

Experimental group

Description:

Subjects aged 4 to 6 years received a dose of lot 3 of SB213503 vaccine and a dose of M-M-R II vaccine. SB213503 was administered by deep intramuscular injection in the left deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Treatment:

Biological: M-M-R II

Biological: SB213503 lot 3

Infanrix + IPOL + M-M-R Group

Active Comparator group

Description:

Subjects aged 4 to 6 years received a dose of Infanrix and a dose of IPOL vaccines separately and a dose of M-M-R II vaccine. Infanrix was administered by deep intramuscular injection in the upper left deltoid. IPOL was administered subcutaneously in the lower right deltoid. M-M-R II was co-administered as a subcutaneous injection in the upper right deltoid.

Treatment:

Biological: M-M-R II

Biological: Infanrix

Biological: IPOL