Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Hexavalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A HEXAVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE

Sponsors

Commanditaire principal: Pfizer

La source Pfizer
Bref résumé

This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational hexavalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.

Situation globale Not yet recruiting
Date de début March 31, 2021
Date d'achèvement April 10, 2022
Date d'achèvement principale April 10, 2022
Phase Phase 2
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Percentages of participants reporting prompted local reactions within 7 days following investigational product administration Day 7
Percentages of participants reporting prompted systemic events within 7 days following investigational product administration Day 7
Percentages of participants reporting adverse events (AEs) through 1 month following investigational product administration 1 month following administration of investigational product
Percentages of participants reporting medically attended adverse events (MAEs) and serious adverse events (SAEs) through 6 months following investigational product administration 6 months following administration of investigational product
Difference in percentages of participants with anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between the GBS6 and Tdap group and the placebo and Tdap group 1 month after investigational product administration
Difference in percentages of participants with anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between GBS6 and Tdap group and placebo and Tdap group 1 month after investigational product administration
Geometric mean concentration (GMC) ratio, estimated by the ratio of the GMC of anti-pertussis toxin antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination. 1 month after investigational product administration
GMC ratio, estimated by the ratio of the GMC of anti-filamentous hemagglutinin (anti-FHA) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination. 1 month after investigational product administration
GMC ratio, estimated by the ratio of the GMC of antipertactin (anti-PRN) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination. 1 month after investigational product administration
GBS capsular polysaccharide (CPS) serotype-specific IgG GMC ratio, estimated by the ratio of the GMC of GBS CPS serotype-specific IgG antibodies from the GBS6 and Tdap group to the GBS6 and placebo group measured 1 month after vaccination. 1 month after investigational product administration
Inscription 1740
État
Intervention

Type d'intervention: Biological

Nom de l'intervention: Hexavalent Group B streptococcus vaccine

La description: Hexavalent Group B streptococcus vaccine

Type d'intervention: Biological

Nom de l'intervention: Tetanus, diphtheria, and acellular pertussis vaccine

La description: Tetanus, diphtheria, and acellular pertussis vaccine

Autre nom: Tdap

Type d'intervention: Biological

Nom de l'intervention: Placebo

La description: Saline control

Admissibilité

Critères:

Inclusion Criteria: - Healthy women ≥18 and ≤49 years of age. - Participants who are willing and able to comply with scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures, including completion of the e-diary from Day 1 to Day 7 following administration of investigational product. - Healthy females at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. - Expected to be available for the duration of the study and who can be contacted by telephone during study participation. - Capable of giving personal signed informed consent. Exclusion Criteria: - Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination) - History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197-containing vaccine. - History of microbiologically proven invasive disease caused by group B streptococcus. - Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. - Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during the participant's participation in the study (through the 6-month follow-up visit [Visit 3]). - Vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (Tdap) before investigational product administration.

Le sexe: Female

Basé sur le genre: Yes

Sexe Description: Healthy women ≥18 and ≤49 years of age.

Âge minimum: 18 Years

Âge maximum: 49 Years

Volontaires en santé: Accepts Healthy Volunteers

Officiel général
Nom de famille Rôle Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Contact général

Nom de famille: Pfizer CT.gov Call Center

Téléphone: 1-800-718-1021

Email: [email protected]

Date de vérification

February 2021

Partie responsable

Type: Sponsor

A un accès étendu No
Parcourir l'état
Nombre d'armes 3
Groupe d'armes

Étiquette: GBS6 and Tdap

Type: Experimental

La description: Hexavalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Étiquette: GBS6 and Placebo

Type: Experimental

La description: Hexavalent group B streptococcus vaccine and Placebo

Étiquette: Placebo and Tdap

Type: Experimental

La description: Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Données patient Yes
Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Parallel Assignment

Objectif principal: Prevention

Masquage: Double (Participant, Investigator)

Description du masquage: This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the subject, will be blinded.

La source: ClinicalTrials.gov