Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal; Meningococcal Vaccines

Treatments: Biological: Synflorix™; Biological: Infanrix™ hexa; Biological: Menjugate®; Biological: NeisVac-CTM; Biological: Nimenrix™

Study type: Interventional

Funder types: Industry

Identifiers

NCT01144663

2009-016841-24 (EudraCT Number)

113369

Details and patient eligibility

About

The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.

Full description

The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.

Enrollment: 2,095 patients

Sex: All

Ages: 6 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

All subjects must satisfy ALL the following criteria at study entry:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
• A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
• Written informed consent obtained from the parent(s) or guardian of the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Born after a gestation period of at least 36 weeks.

Exclusion criteria

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national recommendations.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
• Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example hepatitis B and BCG).
• History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures (history of a single, simple febrile seizure is permitted).
• Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting).

(Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator).

• Administration of immunoglobulins and/ or any blood products since birth or planned administration during the study period.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,095 participants in 4 patient groups

Nimenrix 3 Group

Experimental group

Description:

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age.

Treatment:

Biological: Synflorix™

Biological: Infanrix™ hexa

Biological: Nimenrix™

Nimenrix 2 Group

Experimental group

Description:

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.

Treatment:

Biological: Synflorix™

Biological: Infanrix™ hexa

Biological: Nimenrix™

Menjugate Group

Active Comparator group

Description:

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.

Treatment:

Biological: Menjugate®

Biological: Synflorix™

Biological: Infanrix™ hexa

NeisVac-C Group

Active Comparator group

Description:

Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age.

Treatment:

Biological: NeisVac-CTM

Biological: Synflorix™

Biological: Infanrix™ hexa