Group B Streptococcal InfectionsPhase 2NCT03170609

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 Adults 18 To 49 Years Of Age

A Phase 2 study testing Multivalent group B streptococcus vaccine in people with Group B Streptococcal Infections, run by Pfizer at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single… Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Group B Streptococcal Infections
What is being tested?: Multivalent group B streptococcus vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 365 participants
Where: 4 sitesUnited States
Study dates: 5 Jun 2017to 25 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults (male and female) 18 to 49 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 for all female subjects who are of childbearing potential.

Who cannot join

Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product.
Acute or chronic medical or psychiatric condition 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. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus 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).

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Kentucky Pediatric / Adult Research
Bardstown, Kentucky, 40004
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
Clinical Research Atlanta
Stockbridge, Georgia, 30281

Other trials in United States

About this study

Official title: 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 ADULTS 18 TO 49 YEARS OF AGE

Conditions: Group B Streptococcal Infections
Being tested: Multivalent group B streptococcus vaccine, Placebo
Medical subject headings: Streptococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Multivalent group B streptococcus vaccineBiological
Various formulations at three dose levels
PlaceboBiological
Saline Control

Study groups in NCT03170609
Study group	Role	What they receive
Lowest dose formulation a	Experimental	Multivalent group B streptococcus vaccine Receives: Biological: Multivalent group B streptococcus vaccine
Middle dose formulation a	Experimental	Multivalent group B streptococcus vaccine Receives: Biological: Multivalent group B streptococcus vaccine
Highest dose formulation a	Experimental	Multivalent group B streptococcus vaccine Receives: Biological: Multivalent group B streptococcus vaccine
Lowest dose formulation b	Experimental	Multivalent group B streptococcus vaccine Receives: Biological: Multivalent group B streptococcus vaccine
Middle dose formulation b	Experimental	Multivalent group B streptococcus vaccine Receives: Biological: Multivalent group B streptococcus vaccine
Highest dose formulation b	Experimental	Multivalent group B streptococcus vaccine Receives: Biological: Multivalent group B streptococcus vaccine
Placebo	Placebo comparator	Saline control Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade
Hemoglobin:Grade(G)1: 11-13.5g/dL, G2:9.5-12.4g/dL,G3:8-10.4 g/dL, G4:<8.0 g/dL; leukocyte increase:G1: 10.8-15*10^9/Liter[L],G2:>15-20*10^9/L, G3:>20-25*10^9/L, G4:>25*10^9/L,leukocyte decrease: G1: 2.5-3.5*10^9/L, G2: 1.5-<2.5*10^9/L, G3: 1-<1.5*10^9/L, G4:<1*10^9/L; neutrophil decrease:G1: 1.5-2*10^9/L, G2:1-<1.5*10^9/L, G3:0.5-<1*10^9/L,G4:<0.5*10^9/L; platelets:G1: 125-140*10^9/L, G2:100-124*10^9/L, G3:25-99*10^9/L, G4:<25*10^9/L; eosinophils: G1: 0.65-1.5*10^9/L, G2:>1.5-5*10^9/L, G3:>5*10^9/L, G4: hypereosinophilic;alanine aminotransferase,aspartate aminotransferase:G1: 1.1-2.5 *ULN, G2:2.6-5.0*ULN, G3:5.1-10*ULN, G4:>10*ULN; alkaline phosphatase:G1: 1.1-2*ULN, G2:2.1-3*ULN, G3:3.1-10*ULN, G4:>10*ULN; Bilirubin:G1: 1.1-1.5*ULN, G2: 1.26-2*ULN,G3: 1.51-3.0*ULN,G4:>1.75*ULN;blood urea nitrogen:G1:23-26mg/dL,G2:27-31mg/dL,G3:>31mg/dL, G4:dialysis;creatinine:G1:1.5-1.7mg/dL,G2:1.8-2mg/dL,G3:2.1-2.5 mg/dL,G4:dialysis.Categories with>=1 participant with abnormality are reported only.
Measured: 1 week after vaccination
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination
Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm) and severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.
Measured: Within 14 days after vaccination
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination
Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours[hr]),moderate(some interference with activity/>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever >24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.
Measured: Within 14 days after vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.
Measured: Within 1 month after vaccination
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
Measured: Within 6 months after vaccination
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.
Measured: Within 6 months after vaccination

Secondary outcomes (1)

GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination
Serotypes used for evaluation were: Ia, Ib, II, III, IV, and V.
Measured: 1 month after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 201725 Jun 2018

First posted31 May 2017
Study start5 Jun 2017
Primary completion25 Jun 2018
Study completion25 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Group B Streptococcal InfectionsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 365 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03170609
Sponsor's protocol ID: C1091001
Status last verified: Jun 2019
First submitted: 26 May 2017
Last updated: 2 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, Peng Y, Munson S, Pavliakova D, Scott DA, Anderson AS. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. Lancet Infect Dis. 2021 Feb;21(2):263-274. doi: 10.1016/S1473-3099(20)30478-3. Epub 2020 Sep 3.
PubMed 32891191

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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 ADULTS 18 TO 49 YEARS OF AGE
ClinicalTrials.gov ID: NCT03170609
Acronym / sponsor ID: C1091001
Conditions: Group B Streptococcal Infections
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 365 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 5 Jun 2017 (actual)
Primary completion: 25 Jun 2018 (actual)
Study completion: 25 Jun 2018 (actual)
First posted: 31 May 2017 (actual)
Results: Posted 2 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Lowest dose formulation a	Experimental	Biological: Multivalent group B streptococcus vaccineMultivalent group B streptococcus vaccine
Middle dose formulation a	Experimental	Biological: Multivalent group B streptococcus vaccineMultivalent group B streptococcus vaccine
Highest dose formulation a	Experimental	Biological: Multivalent group B streptococcus vaccineMultivalent group B streptococcus vaccine
Lowest dose formulation b	Experimental	Biological: Multivalent group B streptococcus vaccineMultivalent group B streptococcus vaccine
Middle dose formulation b	Experimental	Biological: Multivalent group B streptococcus vaccineMultivalent group B streptococcus vaccine
Highest dose formulation b	Experimental	Biological: Multivalent group B streptococcus vaccineMultivalent group B streptococcus vaccine
Placebo	Placebo comparator	Biological: PlaceboSaline control

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy adults (male and female) 18 to 49 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 for all female subjects who are of childbearing potential.

Key exclusion criteria (5 listed)

Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for at least 3 months after the last dose of investigational product.
Acute or chronic medical or psychiatric condition 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. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus 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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Multivalent group B streptococcus vaccineVarious formulations at three dose levels	Biological	Highest dose formulation a, Highest dose formulation b, Lowest dose formulation a, Lowest dose formulation b, Middle dose formulation a, Middle dose formulation b
PlaceboSaline Control	Biological	Placebo

Primary outcome

Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade
Time frame: 1 week after vaccination
Hemoglobin:Grade(G)1: 11-13.5g/dL, G2:9.5-12.4g/dL,G3:8-10.4 g/dL, G4:<8.0 g/dL; leukocyte increase:G1: 10.8-15*10^9/Liter[L],G2:>15-20*10^9/L, G3:>20-25*10^9/L, G4:>25*10^9/L,leukocyte decrease: G1: 2.5-3.5*10^9/L, G2: 1.5-<2.5*10^9/L, G3: 1-<1.5*10^9/L, G4:<1*10^9/L; neutrophil decrease:G1: 1.5-2*10^9/L, G2:1-<1.5*10^9/L, G3:0.5-<1*10^9/L,G4:<0.5*10^9/L; platelets:G1: 125-140*10^9/L, G2:100-124*10^9/L, G3:25-99*10^9/L, G4:<25*10^9/L; eosinophils: G1: 0.65-1.5*10^9/L, G2:>1.5-5*10^9/L, G3:>5*10^9/L, G4: hypereosinophilic;alanine aminotransferase,aspartate aminotransferase:G1: 1.1-2.5 *ULN, G2:2.6-5.0*ULN, G3:5.1-10*ULN, G4:>10*ULN; alkaline phosphatase:G1: 1.1-2*ULN, G2:2.1-3*ULN, G3:3.1-10*ULN, G4:>10*ULN; Bilirubin:G1: 1.1-1.5*ULN, G2: 1.26-2*ULN,G3: 1.51-3.0*ULN,G4:>1.75*ULN;blood urea nitrogen:G1:23-26mg/dL,G2:27-31mg/dL,G3:>31mg/dL, G4:dialysis;creatinine:G1:1.5-1.7mg/dL,G2:1.8-2mg/dL,G3:2.1-2.5 mg/dL,G4:dialysis.Categories with>=1 participant with abnormality are reported only.
Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Local reactions were collected by using an e-diary and included redness, swelling and pain at injection site. Redness and swelling were graded as: mild (2.5-5.0 centimeter [cm]), moderate (greater than [>] 5.0-10.0 cm) and severe (>10.0 cm), grade 4 for redness (necrosis or exfoliative dermatitis) and grade 4 for swelling (necrosis). Pain at injection site was graded as: mild (did not interfere with activity), moderate (repeated use of nonnarcotic pain reliever >24 hours or interfered with activity), severe (any use of narcotic pain reliever or prevented daily activity which resulted in missed days of work or school or was otherwise incapacitating, or included use of narcotics for analgesia), and grade 4 (required emergency room visit or hospitalization). The maximum severity (highest grading) of each location reaction within 14 days of vaccination was derived.
Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination
Time frame: Within 14 days after vaccination
Fever:38.0-38.4 degree Celsius (C),38.5-38.9 degree C,39.0-40.0 degree C,>40.0 degree C;nausea/vomiting:mild(not interfered with activity/1-2times in 24 hours[hr]),moderate(some interference with activity/>2times in 24hr),severe(prevented daily activity;required intravenous hydration); diarrhea:mild(2-3 loose stools in 24hr),moderate(4-5 loose stools in 24hr),severe(>=6 loose stools in 24 hr); headache:mild(not interfered with activity),moderate(repeated use of non-narcotic pain reliever >24 hr/some interference with activity),severe(significant;any use of narcotic pain reliever/prevented daily activity);fatigue,muscle and joint pain:mild(not interfered with activity), moderate(some interference with activity),severe(significant;prevented daily activity).Prevented daily activity=missed days of work, school/otherwise incapacitating/use of narcotics for analgesia.Nausea/vomiting,diarrhea,headache,fatigue/tiredness,muscle and joint pain: grade 4=emergency room visit or hospitalization.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Time frame: Within 1 month after vaccination
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. AEs included both non-serious AEs and SAEs.
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination
Time frame: Within 6 months after vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event.
Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination
Time frame: Within 6 months after vaccination
An AE was any untoward medical occurrence in a participant in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or that was considered to be an important medical event. An MAE was defined as a non serious AE (AE other than SAE) that resulted in an evaluation at a medical facility.

1 secondary outcome

GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination
Time frame: 1 month after vaccination

Results and safety

Results posted to the registry on 2 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GBS6 5 Microgram With Aluminum Phosphate	53	50
GBS6 5 Microgram Without Aluminum Phosphate	52	50
GBS6 10 Microgram With Aluminum Phosphate	52	46
GBS6 10 Microgram Without Aluminum Phosphate	52	50
GBS6 20 Microgram With Aluminum Phosphate	52	51
GBS6 20 Microgram Without Aluminum Phosphate	52	50
Placebo	52	51

Primary outcome: Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade

Time frame: 1 week after vaccination. Number. Unit: percentage of participants

Measure	GBS6 5 Microgram With Aluminum Phosphate n = 16	GBS6 5 Microgram Without Aluminum Phosphate n = 16	GBS6 10 Microgram With Aluminum Phosphate n = 16	GBS6 10 Microgram Without Aluminum Phosphate n = 16	GBS6 20 Microgram With Aluminum Phosphate n = 16	GBS6 20 Microgram Without Aluminum Phosphate n = 16	Placebo n = 24
Hemoglobin: Grade 1	0	6.3	12.5	0	0	6.3	0
Hemoglobin: Grade 2	6.3	0	0	0	0	0	0
Platelets: Grade 1	0	0	6.3	6.7	0	0	0
Leukocyte decrease:Grade 1	6.3	6.3	0	0	0	0	0
Leukocyte increase: Grade 1	0	0	0	0	0	6.3	0
Leukocyte increase: Grade 2	0	0	0	0	0	0	4.2
Neutrophils decrease(Absolute): Grade 1	6.3	18.8	0	0	0	6.3	0
Neutrophils decrease (Absolute): Grade 2	0	0	0	0	6.3	0	0

Population analysed: Analysis population for this outcome measure included a subset of participants who received GBS6 vaccine or placebo.

Primary outcome: Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination

Time frame: Within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	GBS6 5 Microgram With Aluminum Phosphate n = 52	GBS6 5 Microgram Without Aluminum Phosphate n = 52	GBS6 10 Microgram With Aluminum Phosphate n = 52	GBS6 10 Microgram Without Aluminum Phosphate n = 52	GBS6 20 Microgram With Aluminum Phosphate n = 52	GBS6 20 Microgram Without Aluminum Phosphate n = 52	Placebo n = 52
Pain:Any	53.8 (39.5 to 67.8)	32.7 (20.3 to 47.1)	48.1 (34.0 to 62.4)	38.5 (25.3 to 53.0)	51.9 (37.6 to 66.0)	25.0 (14.0 to 38.9)	15.4 (6.9 to 28.1)
Pain:Mild	51.9 (37.6 to 66.0)	28.8 (17.1 to 43.1)	44.2 (30.5 to 58.7)	36.5 (23.6 to 51.0)	42.3 (28.7 to 56.8)	19.2 (9.6 to 32.5)	13.5 (5.6 to 25.8)
Pain:Moderate	1.9 (0.0 to 10.3)	3.8 (0.5 to 13.2)	3.8 (0.5 to 13.2)	1.9 (0.0 to 10.3)	9.6 (3.2 to 21.0)	5.8 (1.2 to 15.9)	1.9 (0.0 to 10.3)
Pain:Severe	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)
Pain:Grade 4	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)
Redness:Any	0 (0.0 to 6.8)	3.8 (0.5 to 13.2)	1.9 (0.0 to 10.3)	0 (0.0 to 6.8)	5.8 (1.2 to 15.9)	0 (0.0 to 6.8)	0 (0.0 to 6.8)
Redness:Mild	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	5.8 (1.2 to 15.9)	0 (0.0 to 6.8)	0 (0.0 to 6.8)
Redness:Moderate

Primary outcome: Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination

Time frame: Within 14 days after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	GBS6 5 Microgram With Aluminum Phosphate n = 52	GBS6 5 Microgram Without Aluminum Phosphate n = 52	GBS6 10 Microgram With Aluminum Phosphate n = 52	GBS6 10 Microgram Without Aluminum Phosphate n = 52	GBS6 20 Microgram With Aluminum Phosphate n = 52	GBS6 20 Microgram Without Aluminum Phosphate n = 52	Placebo n = 52
Fever:>=38.0 degree C	0 (0.0 to 6.8)	0 (0.0 to 6.8)	1.9 (0.0 to 10.3)	0 (0.0 to 6.8)	1.9 (0.0 to 10.3)	1.9 (0.0 to 10.3)	1.9 (0.0 to 10.3)
Fever:38.0 to 38.4 degree C	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	1.9 (0.0 to 10.3)	0 (0.0 to 6.8)
Fever:38.5 to 38.9 degree C	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	1.9 (0.0 to 10.3)	0 (0.0 to 6.8)	1.9 (0.0 to 10.3)
Fever:39.0 to 40.0 degree C	0 (0.0 to 6.8)	0 (0.0 to 6.8)	1.9 (0.0 to 10.3)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)
Fever:>40.0 degree C	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)	0 (0.0 to 6.8)
Nausea/vomiting: Any	13.5 (5.6 to 25.8)	5.8 (1.2 to 15.9)	11.5 (4.4 to 23.4)	17.3 (8.2 to 30.3)	9.6 (3.2 to 21.0)	11.5 (4.4 to 23.4)	21.2 (11.1 to 34.7)
Nausea/vomiting: Mild	9.6 (3.2 to 21.0)	3.8 (0.5 to 13.2)	9.6 (3.2 to 21.0)	11.5 (4.4 to 23.4)	7.7 (2.1 to 18.5)	9.6 (3.2 to 21.0)	13.5 (5.6 to 25.8)

Primary outcome: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

Time frame: Within 1 month after vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	GBS6 5 Microgram With Aluminum Phosphate n = 52	GBS6 5 Microgram Without Aluminum Phosphate n = 52	GBS6 10 Microgram With Aluminum Phosphate n = 52	GBS6 10 Microgram Without Aluminum Phosphate n = 52	GBS6 20 Microgram With Aluminum Phosphate n = 52	GBS6 20 Microgram Without Aluminum Phosphate n = 52	Placebo n = 52
Value	19.2 (9.6 to 32.5)	5.8 (1.2 to 15.9)	19.2 (9.6 to 32.5)	13.5 (5.6 to 25.8)	26.9 (15.6 to 41.0)	28.8 (17.1 to 43.1)	21.2 (11.1 to 34.7)

Population analysed: Safety population included all participants who received GBS6 vaccine or placebo.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Local reactions and systemic events: within 14 days after vaccination on Day 1 and all AEs other than local reactions and systemic events: within 6 Months after vaccination on Day 1. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GBS6 5 Microgram With Aluminum Phosphate	1 of 52 (1.9%)	40 of 52 (76.9%)	0 of 52
GBS6 5 Microgram Without Aluminum Phosphate	0 of 52 (0%)	35 of 52 (67.3%)	0 of 52
GBS6 10 Microgram With Aluminum Phosphate	1 of 52 (1.9%)	39 of 52 (75%)	1 of 52
GBS6 10 Microgram Without Aluminum Phosphate	0 of 52 (0%)	36 of 52 (69.2%)	0 of 52
GBS6 20 Microgram With Aluminum Phosphate	1 of 52 (1.9%)	41 of 52 (78.8%)	0 of 52
GBS6 20 Microgram Without Aluminum Phosphate	0 of 52 (0%)	36 of 52 (69.2%)	0 of 52
Placebo	0 of 52 (0%)	35 of 52 (67.3%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32891191Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, Peng Y, Munson S, Pavliakova D, Scott DA, Anderson AS. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. Lancet Infect Dis. 2021 Feb;21(2):263-274. doi: 10.1016/S1473-3099(20)30478-3. Epub 2020 Sep 3.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Multivalent group B streptococcus vaccine in people with Group B Streptococcal Infections, run by Pfizer at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade (time frame: 1 week after vaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03170609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019; AzTrials last refreshed its copy on 26 Oct 2026.