CompletedPhase 2

Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants

United States1,208 participantsStarted 2019-01-14

Plain-language summary

Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety, tolerability and immunogenicity of the investigational multivalent group B streptococcus vaccine administered at one dose level (various formulations) in healthy nonpregnant women (various formulations at one dose level), and then in healthy pregnant women (various formulations at three dose levels), and finally in healthy pregnant women at a selected dose level/formulation.

Who can participate

Age range0 Years – 40 Years

SexALL

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

Inclusion Criteria Stage 1 Nonpregnant Women: * Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. * Negative urine pregnancy test at Visit 1 (prior to vaccination). * Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 1 Booster Vaccination: * Participant must have received investigational product at Visit 1. * Healthy nonpregnant female determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for booster vaccination and received investigational product at Visit 1. * Negative urine pregnancy test at Visit 6 (prior to vaccination). * Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B virus (HBV) infection at screening. Inclusion Criteria Stage 2 and 3 Maternal Participants: * Healthy females \>=18 and \<=40 years of age who are \>=27 0/7 (Stage 2) or \>=24 0/7 (Stage 3) to \<=35 6/7 weeks' gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and at no increased risk for complications and no significant fetal abnormalities observed on ultrasound performed at any time prior to study entry and/or at the screening visit. * Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis tests …

What they're measuring

Percentage of Participants Reporting Local Reactions Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1

Timeframe: Day 1 (day of vaccination) to Day 7 after Primary Dose

Percentage of Participants Reporting Local Reactions Within 7 Days After Booster Dose: Non-Pregnant Women Stage 1

Timeframe: Day 1 (day of vaccination) to Day 7 after booster dose

Percentage of Participants Reporting Systemic Events Within 7 Days After Primary Dose: Non-Pregnant Participants Stage 1

Timeframe: Day 1 (day of vaccination) to Day 7 after primary dose

Percentage of Participants Reporting Systemic Events Within 7 Days After Booster Dose: Non-Pregnant Participants Stage 1

Timeframe: Day 1 (day of vaccination) to Day 7 after booster dose

Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Primary Dose: Non-Pregnant Participants Stage 1

Timeframe: Day 1 (day of vaccination) through 1 Month post primary dose

Percentage of Participants Reporting AEs Through 1 Month After Booster Dose: Non-Pregnant Participants Stage 1

Timeframe: Day 1 (day of vaccination) through 1 Month post booster dose

Trial details

NCT IDNCT03765073

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-04

Results submitted2025-03-04

View on ClinicalTrials.gov More Group B Streptococcus Infections trials