Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age15-17
SponsorPfizer

About this trial

The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®).

This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae

This study is seeking participants who:

* Are children aged 15 months to 18 years. * May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past.

The study will be conducted in the United States, Puerto Rico, and other countries.

Participants will be assigned to 1 of 3 groups based on age:

Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants)

Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC.

Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up).

At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • PG4

    Biological/Vaccine

    Multivalent Pneumococcal Vaccine

  • 20-valent pneumococcal conjugate vaccine (20vPnC)

    Biological/Vaccine

    20-valent pneumococcal conjugate vaccine (20vPnC)

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: PG4 (intramuscular)Experimental treatment 1 intervention
Group B: 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Local Reactions Within 7 Days After Vaccination

Time frame
Within 7 days after Vaccination
2

Percentage of Participants With Systemic Events Within 7 Days after Vaccination

Time frame
Within 7 days after Vaccination
3

Percentage of Participants With Adverse Events (AEs)

Time frame
From Vaccination to 1 month after Vaccination
4

Percentage of Participants With Serious Adverse Events (SAEs)

Time frame
From Vaccination to 6 months after Vaccination

Secondary outcomes

1

Percentage of participants with predefined serotype-specific IgG concentrations

Time frame
1 month after vaccination
2

IgG GMFRs

Time frame
1 month after vaccination
3

Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers

Time frame
before to 1 month after vaccination
4

OPA GMFRs

Time frame
before to 1 month after vaccination

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.