A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age

Pfizer

Status and phase: Completed; Phase 2

Conditions: Pneumococcal Infections

Treatments: Biological: Multivalent; Biological: Tdap; Biological: polysaccharide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03313050

C3571001

Details and patient eligibility

About

This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage.

In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).

In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).

Enrollment: 511 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Stage 1: Healthy male or female adults 50 to 64 years of age with no history of pneumococcal vaccination
• Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated with Prevnar 13 >= 2 months prior to investigational product administration

Exclusion criteria

• Stage 1: Vaccination within 12 months before investigational product administration with diphtheria-, pertussis-, or tetanus-containing vaccine
• Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior dose of Prevnar 13

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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511 participants in 4 patient groups

Stage 1 multivalent (ages 50-64 years)

Experimental group

Description:

multivalent

Treatment:

Biological: Multivalent

Stage 1 Tdap (ages 50-64 years)

Active Comparator group

Description:

Tdap

Treatment:

Biological: Tdap

Stage 2 multivalent (ages 65-85 years)

Experimental group

Description:

multivalent

Treatment:

Biological: Multivalent

Stage 2 polysaccharide (ages 65-85 years)

Active Comparator group

Description:

polysaccharide

Treatment:

Biological: polysaccharide