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7-valent Pneumococcal Conjugate Vaccine

Phase 3

Pneumococcal Infection | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Jun 15, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,674

FDA Designations

No designations recorded

Clinical trial landscape

7-valent Pneumococcal Conjugate Vaccine · 3 trials · 3 indications

Phase 3 1Phase 2 1Phase 1 1
NCT01692886A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In ChinaPneumococcal Infection
COMPLETED1,674 Analytics
PHASE3COMPLETED
A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China
Pneumococcal InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
1 month after the infant series (6 Months of age)
Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
1 month after the infant series (7 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
1 month after the infant series (6 Months of age)
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
1 month after the infant series (7 Months of age)
Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
Approximately 16 months from the participation into the study to the end of study
Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
Approximately 16 months from the participation into study to the end of study
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
Seven days after each pneumococcal vaccination dose within the period up to 12 months
Proportion of patients responders to 7 pneumococcal polysaccharides at W8
Concentration of Serotype-Specific IgG Antibodies
7 months

Vaccine efficacy can be assessed by measuring the levels of antibodies to the specific types (or serotypes) of bacteria covered by the vaccine. IgG antibodies for the 7 pneumococcal serotypes in 7vPnC (4, 6B, 9V, 14, 18C, 19F, 23F) were assessed 30-50 days after the third dose of vaccine. Antibody levels were measured by standardized enzyme-linked immunosorbent assay (ELISA). The minimum level of antibodies required to confer protection has been defined as 0.15 ug/ml by the Northern California Kaiser Permanente (NCKP) study, and as 0.35 ug/ml by the World Health Organization (WHO).

Secondary Endpoints

Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.
1 month after the infant series (6 Months of age)
Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.
1 month after the infant series (7 Months of age)
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.
1 month after the infant series (6 Months of age)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
7vPnC (3-, 4-, 5-, 12-Month)ACTIVE_COMPARATOR -
13vPnC (3-, 4-, 5-, 12-Month)EXPERIMENTAL -
13vPnC (2-, 4-, 6-, 12-Month)EXPERIMENTAL -
13vPnC (3-, 5-, 12-Month)EXPERIMENTAL -

Interventions

NameTypeDescription
7-valent Pneumococcal Conjugate VaccineBIOLOGICALsuspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
13-valent Pnumococcal Conjugate vaccineBIOLOGICALsuspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
7-valent pneumococcal conjugate vaccine (vaccine)BIOLOGICAL -
23-valent pneumococcal conjugate vaccine (vaccine)BIOLOGICAL -
Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP)BIOLOGICAL -
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Eligibility Criteria

Age Range42 Days to 77 Days
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: 1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment. 2. Healthy infant as determined by medical history, physical examination, and judgment of the investigator. Exclusion Criteria: 1. Previous vaccination with licensed or investigational pneumococcal vacci...

Countries:ChinaFrance
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Recent Changes (Last 90 Days)

MEDIUMJul 16, 2026NCT00148824TRIAL_REMOVED: changed
MEDIUMJul 16, 2026NCT00148824TRIAL_REMOVED: changed
MEDIUMJul 16, 2026NCT00148824TRIAL_REMOVED: changed
MEDIUMJul 3, 2026NCT01692886TRIAL_REMOVED: changed
MEDIUMJul 3, 2026NCT01692886TRIAL_REMOVED: changed
MEDIUMJul 3, 2026NCT01692886TRIAL_REMOVED: changed

Frequently asked questions about 7-valent Pneumococcal Conjugate Vaccine

What is 7-valent Pneumococcal Conjugate Vaccine used for?

7-valent Pneumococcal Conjugate Vaccine is used for pneumococcal infection, pneumococcal infections, and HIV infections. It is an investigational vaccine being developed by Pfizer, Inc. (PFE) for the prevention of pneumococcal disease. The vaccine is currently in Phase 3 clinical development.

Who makes 7-valent Pneumococcal Conjugate Vaccine?

Pfizer, Inc. (PFE) is developing 7-valent Pneumococcal Conjugate Vaccine. The vaccine is being studied for pneumococcal infections and HIV infections. It is currently in Phase 3 clinical trials, with one completed Phase 3 study involving 1,674 participants.

What phase is 7-valent Pneumococcal Conjugate Vaccine in?

7-valent Pneumococcal Conjugate Vaccine is in Phase 3 clinical development. It is an investigational vaccine, not yet approved by regulatory authorities. Clinical trials have been completed, including a Phase 3 study in healthy infants in China.

What clinical trials is 7-valent Pneumococcal Conjugate Vaccine in?

7-valent Pneumococcal Conjugate Vaccine has been studied in clinical trials including NCT00148824, NCT00488826, and NCT01692886. NCT01692886 is a Phase 3 study evaluating the vaccine in healthy infants in China, with 1,674 participants. The trials cover pneumococcal infections and HIV infections.

Is 7-valent Pneumococcal Conjugate Vaccine the same as 13-valent Pneumococcal Conjugate Vaccine?

7-valent Pneumococcal Conjugate Vaccine is not the same as 13-valent Pneumococcal Conjugate Vaccine. They are distinct vaccines with different valencies. A clinical trial, NCT01692886, evaluated both vaccines in healthy infants in China, but they are separate products.