A Phase 2 Study to Learn About a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of a Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 11 Through 15 Months of Age Who Previously Received the PCV10 Primary Series

ClinicalTrials.gov ID

NCT06116591

Acronym / sponsor ID

C4801002

Conditions

Healthy Participants

Keywords

Pneumococcal Disease

Phase

Phase 2

Study type

Interventional

Recruitment status

Completed

Enrolment

105 participants (actual)

Lead sponsor

PfizerIndustry (pharma, biotech, devices)

Study start

8 Nov 2023 (actual)

Primary completion

27 May 2024 (actual)

Study completion

27 May 2024 (actual)

First posted

3 Nov 2023 (actual)

Results

Posted 8 May 2025

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

Parallel groups

Masking

None (open label)

Number of arms

2

Who may qualify

Ages

11 to 15 months

Sex

All

Healthy volunteers

Accepted

Age groups

Child

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

Interventions

Primary outcome

1. Percentage of Participants With Local Reactions Within 7 Days After Dose 1

   Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)

   Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 centimeter (cm), moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.

2. Percentage of Participants With Local Reactions Within 7 Days After Dose 2

   Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)

   Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild: > 0 to 2.0 cm, moderate: >2.0 to 7.0 cm, severe: >7.0 cm and Grade 4: necrosis or exfoliative dermatitis (redness) and necrosis (swelling). Pain at injection site was graded as mild: hurt if gently touched, moderate: hurt if gently touched, with crying, severe: caused limitation of limb movement and Grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain at injection site. Grade 4 assessments were made by the investigator. Any local reaction: any mild, moderate, severe, or Grade 4 redness, swelling, or pain at the injection site.

3. Percentage of Participants With Systemic Events Within 7 Days After Dose 1

   Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 1 administration (Visit 1 of study)

   Fever (oral temperature >= 38 degree Celsius [degC]) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.

4. Percentage of Participants With Systemic Events Within 7 Days After Dose 2

   Time frame: Day 1 through Day 7, where Day 1 is the day of Dose 2 administration (Visit 3 of study)

   Fever (oral temperature >= 38 degC) was categorized as >=38.0-38.4 degC, >38.4-38.9 degC, >38.9-40.0 degC and >40.0 degC. Decreased appetite was graded as mild: decreased interest in eating, moderate: decreased oral intake, severe: refusal to feed. Drowsiness was graded as mild: increased/prolonged sleeping bouts, moderate: slightly subdued, interfered daily activity, severe: disabled, not interested in daily activity. Irritability was graded as mild: easily consolable, moderate: required increased attention, severe: inconsolable, crying couldn't be comforted. Grade 4 decreased appetite, drowsiness and irritability events led to emergency room visit or hospitalization and were classified by investigator/medically qualified person. Any systemic event: any fever, decreased appetite, drowsiness, irritability.

5. Percentage of Participants With Adverse Events (AEs) From Dose 1 Through 1 Month After Dose 2

   Time frame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]

   An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.

6. Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 Through 1 Month After Dose 2

   Time frame: From Dose 1 through 1 month after Dose 2 [up to approximately 3.7 months]

   An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or nonpathogenic; other situations as judged by investigator.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• 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.

11 sites in 2 countries: see every site and its status.