CompletedPhase 3

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

United States1,196 participantsStarted 2018-07-27

Plain-language summary

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

Who can participate

Age range6 Weeks – 12 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All subjects must satisfy all the following criteria at study entry: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the eDiary, return for follow-up visits). * Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure. * A male or female between, and including, 42 and 84 days of age (i.e., 6 through 12 weeks) at the time of the 1st vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born full-term (i.e. after a gestation period of ≥ 38 weeks). Exclusion Criteria: If any exclusion criterion applies, the subject must not be included in the study: • Child in care Each subject must not have: * Progressive, unstable or uncontrolled clinical conditions. * Hypersensitivity, including allergy to any component of vaccines, medicinal product or medical equipment whose use is foreseen in this study. * Hypersensitivity to latex. * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * Abnormal function of the immune system resulting from: * Clinical conditions. * Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth. * Administration of antineoplastic and immunomodulating agents or radioth…

What they're measuring

Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1

Timeframe: Day 1 to Day 7

Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1

Timeframe: Day 1 to Day 7

Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61

Timeframe: Day 61 to Day 67

Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61

Timeframe: Day 61 to Day 67

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127

Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301

Timeframe: Day 301 to Day 307

Trial details

NCT IDNCT03621670

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-27

Results submitted2025-12-23

View on ClinicalTrials.gov More Infections, Meningococcal trials

Plain-language summary

Who can participate

Age range6 Weeks – 12 Weeks

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Reporting Any Solicited Administration Site Events After the First Vaccination Administered at Day 1

Timeframe: Day 1 to Day 7

Number of Participants Reporting Any Solicited Systemic Events After the First Vaccination Administered at Day 1

Timeframe: Day 1 to Day 7

Number of Participants Reporting Any Solicited Administration Site Events After the Second Vaccination Administered at Day 61

Timeframe: Day 61 to Day 67

Number of Participants Reporting Any Solicited Systemic Events After the Second Vaccination Administered at Day 61

Timeframe: Day 61 to Day 67

Number of Participants Reporting Any Solicited Administration Site Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127

Number of Participants Reporting Any Solicited Systemic Events After the Third Vaccination Administered at Day 121

Timeframe: Day 121 to Day 127

Number of Participants Reporting Any Solicited Administration Site Events After the Fourth Vaccination Administered at Day 301

Timeframe: Day 301 to Day 307