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The purpose of this phase 3 multicenter, double-blinded, placebo-controlled study in India is to learn about the safety and immunogenicity of RSVpreF in adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSVpreF | Experimental | RSVpreF Vaccine |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVpreF | Biological | RSVpreF Vaccine |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants reporting local reactions within 7 days following investigational product administration | Describe local reactions following investigational product administration | Within 7 days |
| Percentage of participants reporting systemic events within 7 days following investigational product administration | Describe systemic events following investigational product administration | Within 7 days |
| Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration | Describe AEs occurring through 1 month following administration of investigational product | 1 month after vaccination |
| Percentage of participants reporting serious adverse events (SAEs) throughout the study | Describe SAEs through 3 months following administration of investigational product | 3 months after vaccination |
| Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titers (GMT) | Before vaccination, 1 month after vaccination | |
| NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR) | Before vaccination, 1 month after vaccination | |
| NTs for RSV A and RSV B expressed as seroresponse rate | 1 month after vaccination |
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Key Inclusion Criteria:
Note: A chronic medical condition for this study is defined as:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King George Hospital | Visakhapatnam | Andhra Pradesh | 530002 | India | ||
| BGS Global Institute of Medical Sciences (BGSGIMS) |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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Double-blinded, placebo-controlled.
| Biological |
Placebo |
|
| Bangalore |
| Karnataka |
| 560060 |
| India |
| Radhakrishna Multispeciality Hospital and IVF Center | Bangalore | Karnataka | 560085 | India |
| Belagavi Institute of Medical Sciences - Belagavi | Belagavi | Karnataka | 590001 | India |
| Suyog Hospital | Nashik | Maharashtra | 422003 | India |
| Aakash Healthcare Private Limited | Dwarka | National Capital Territory of Delhi | 110075 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| Maharaja Agrasen Superspeciality Hospital | Jaipur | Rajasthan | 302039 | India |
| SRM Medical College Hospital and Research Centre - Kattankulathur | Chengalpattu | Tamil Nadu | 603203 | India |
| Chettinad Hospital and Research Institute | Kelambākkam | Tamil Nadu | 603103 | India |