Trials / Completed
CompletedNCT05372575
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHILDREN AGED 5 MONTHS TO ≤60 MONTHS AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 5 Months – 60 Months
- Healthy volunteers
- Not accepted
Summary
This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency, Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PCV13 PAC study | To test the serotype-specific IgG geometric mean concentration (GMC) and MOPA geometric mean titers (GMT) for each of the pneumococcal serotypes measured at the time of diagnosis of clinical pneumonia. |
Timeline
- Start date
- 2019-08-15
- Primary completion
- 2021-12-14
- Completion
- 2021-12-14
- First posted
- 2022-05-12
- Last updated
- 2023-10-03
- Results posted
- 2023-10-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05372575. Inclusion in this directory is not an endorsement.