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7-valent pneumococcal conjugate vaccine

Phase 3

Pneumococcal Infection | Vaccine | Infectious Disease |Pfizer, Inc.|Trials Updated: Jun 15, 2026

7-valent pneumococcal conjugate vaccine development status

Highest phase Phase 3
Registered trials 10 across 2 sponsors since Aug 2006

7-valent pneumococcal conjugate vaccine target and mechanism

ModalityVaccine

Also known as 7-Valent Pneumococcal Conjugate Vaccine (7vPnC), 7-valent pneumococcal conjugate vaccine (vaccine), 7vPnC

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment2,686

FDA Designations

No designations recorded

7-valent pneumococcal conjugate vaccine clinical trials

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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Frequently asked questions about 7-valent pneumococcal conjugate vaccine

What is the 7-valent pneumococcal conjugate vaccine used for?

The 7-valent pneumococcal conjugate vaccine is a vaccine designed to prevent pneumococcal infection. It has also been studied in people with HIV infections. It is given to healthy infants and to adults, including those with HIV, to stimulate immune protection against pneumococcal disease.

Who makes the 7-valent pneumococcal conjugate vaccine?

The 7-valent pneumococcal conjugate vaccine is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company associated with the clinical development program for this vaccine.

What phase is the 7-valent pneumococcal conjugate vaccine in?

The 7-valent pneumococcal conjugate vaccine is in Phase 2 clinical development. It is an investigational vaccine and is not approved. The program includes completed Phase 1 and Phase 2 trials, with a total of 2,474 participants enrolled across its studies.

What clinical trials is the 7-valent pneumococcal conjugate vaccine in?

The 7-valent pneumococcal conjugate vaccine has been studied in completed trials including NCT00488826, a Phase 1 study in healthy infants, and NCT00148824, a Phase 2 study of antibody responses to pneumococcal vaccines among HIV-infected adults in France. A related Phase 3 study, NCT01692886, evaluated the 13-valent pneumococcal conjugate vaccine in healthy infants in China.

Is the 7-valent pneumococcal conjugate vaccine the same as 7vPnC?

Yes, 7vPnC is an abbreviation for the 7-valent pneumococcal conjugate vaccine. Other common forms of the name include 7 valent pneumococcal conjugate vaccine and 7-Valent Pneumococcal Conjugate Vaccine (7vPnc). These all refer to the same vaccine.