You are here

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

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre
Hillbrow, Johannesburg, Gauteng, 2001 South Africa
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Group B Streptococcus Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-40
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 2 and 3 Maternal Subjects:

- Healthy females >=18 and 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 at screening.

Inclusion Criteria Stage 2 and 3 Infant Subjects:

Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to
comply with scheduled visits, investigational plan, laboratory tests, and other study
procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Acute or chronic medical or psychiatric condition including recent (within the past
year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.

- 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 GBS (S agalactiae).

- Previous vaccination with any licensed or investigational group B streptococcus
vaccine, or planned receipt during the subject's participation in the study (through
the last blood draw).

Exclusion criteria Stage 2 and 3 Maternal Subjects:

- Acute or chronic medical or psychiatric condition including recent (within the past
year) or active suicidal ideation or behavior or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study.

- 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 GBS (S agalactiae).

- Previous vaccination with any licensed or investigational group B streptococcus
vaccine, or planned receipt during the subject's participation in the study (through
the last blood draw).

- Body mass index (BMI) of >=40 kg/m2 at the time of the screening visit.

- A prior history of or current pregnancy complications or abnormalities that will
increase the risk associated with the subject's participation.

- Major illness of the mother or conditions of the fetus that, in the investigator's
judgment, will substantially increase the risk associated with the subject's
participation in, and completion of, the study or could preclude the evaluation of the
subject's response.

Exclusion criteria Stage 2 and 3 Infant Subjects:

Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

NCT03765073
Pfizer
Not yet recruiting
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

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.
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
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women 18 To 40 Years Of Age And Their Infants
This 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
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.

Primary Purpose: Prevention

Group B Streptococcus Infections
  • Biological: Multivalent Group B streptococcus vaccine
    Various formulations at three dose levels
  • Biological: Placebo
    Saline control
  • Experimental: Stage 1 - Highest dose formulation a
    Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 1 - Highest dose formulation b
    Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Lowest dose formulation a
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Lowest dose formulation b
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Middle dose formulation a
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Middle dose formulation b
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Highest dose formulation a
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 2 - Highest dose formulation b
    Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Experimental: Stage 3 - Selected dose and formulation
    Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
    Intervention: Biological: Multivalent Group B streptococcus vaccine
  • Placebo Comparator: Stage 1 Placebo
    Saline control
    Intervention: Biological: Placebo
  • Placebo Comparator: Stage 2 Placebo
    Saline control
    Intervention: Biological: Placebo
  • Placebo Comparator: Stage 3 Placebo
    Saline control
    Intervention: Biological: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
586
Same as current
May 31, 2022
May 31, 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria Stage 1 Nonpregant 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 2 and 3 Maternal Subjects:

  • Healthy females >=18 and <=40 years of age who are between 27 0/7 and 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 at screening.

Inclusion Criteria Stage 2 and 3 Infant Subjects:

Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to comply with scheduled visits, investigational plan, laboratory tests, and other study procedures.

Exclusion Criteria Stage 1 Nonpregnant Women:

  • Acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • 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 GBS (S agalactiae).
  • Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).

Exclusion criteria Stage 2 and 3 Maternal Subjects:

  • Acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • 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 GBS (S agalactiae).
  • Previous vaccination with any licensed or investigational group B streptococcus vaccine, or planned receipt during the subject's participation in the study (through the last blood draw).
  • Body mass index (BMI) of >=40 kg/m2 at the time of the screening visit.
  • A prior history of or current pregnancy complications or abnormalities that will increase the risk associated with the subject's participation.
  • Major illness of the mother or conditions of the fetus that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in, and completion of, the study or could preclude the evaluation of the subject's response.

Exclusion criteria Stage 2 and 3 Infant Subjects:

Infant who is a direct descendant (eg, child or grandchild) of the study personnel.

Sexes Eligible for Study: All
up to 40 Years   (Child, Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
South Africa
 
 
NCT03765073
C1091002
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now