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The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine. It will be studied in infants born to mothers living with HIV. These infants may have higher chances of getting sick or dying due to RSV infection. Respiratory Syncytial Virus (RSV) is a common type of virus (germ) that can cause severe illness (airway diseases), where medical help is needed. Vaccines help your body make antibodies which help fight against diseases. The antibodies are substances your body uses to fight off an infection. The antibodies can be passed to the infant through the placenta of the mother.
The study will look at the safety, tolerability, and immune activity in mothers and their infants.
This study is seeking pregnant women who are:
Participants will either receive:
Pregnant participants will be involved in the study from:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSVpreF vaccine | Experimental | RSV vaccine (RSVpreF) |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVpreF vaccine | Biological | RSVpreF vaccine |
| |
| Placebp |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination | Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured by the maternal participant and recorded in measuring device units (mdu) in the e-diary (range: 1 to 21). 1 mdu = 0.5 centimetre (cm). Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for severe pain at the injection site). Grade 4 reactions were classified by the investigator or medically qualified designee. | From Day 1 to Day 7 after vaccination |
| Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination | Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in the e-diary. Fever was defined as an oral temperature greater than or equal to (>=) 38.0 degree Celsius (C) and classified as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C) and grade 4 (>40.0 degree C). Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity). Vomiting: mild (1-2 times in 24 hours [H]), moderate (>2 times in 24 H), severe (required intravenous [IV] hydration). Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (>=6 loose stools in 24 H). For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by investigator or medically qualified designee. | From Day 1 to Day 7 after vaccination |
| Percentage of Maternal Participants With Adverse Events (AEs) From the Time of Vaccination Through 1 Month After Vaccination | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included in this outcome measure. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Neutralizing Titer (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Before Vaccination and at Delivery: Maternal Participants | GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the neutralizing titers and the corresponding CIs based on the Student t distribution. |
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Key Inclusion Criteria - Maternal Participants
Key Inclusion Criteria - Infant Participants
Key Exclusion Criteria - Maternal Participants
Key Exclusion Criteria - Infant Participants
• Infant who is a direct descendant (eg, child or grandchild) of the investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Biomed Research Institute | East London | Eastern Cape | 5241 | South Africa | ||
| Josha Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41441684 | Derived | Myer L, Wasserman E, Tabasum S, Shittu E, Liu Y, Jose L, Horne E, Moraba RS, Wilhase A, Zar HJ, Hussen N, Mogashoa MS, Malahleha M, Madhi SA, Sarwar UN, Snaggs H, Erdem R, Radley D, Kalinina EV, Pahud BA, Maddalena Lino M, Anastasiou OE, Swanson KA, Anderson AS, Gurtman A, Munjal I. Safety, Tolerability, and Immunogenicity of RSVpreF Vaccine in Pregnant Individuals Living with HIV. Vaccines (Basel). 2025 Dec 1;13(12):1218. doi: 10.3390/vaccines13121218. |
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Maternal Participants: RSVpreF | Study-eligible pregnant women (maternal participants) living with human immunodeficiency virus (HIV) were randomized to receive a single dose of 120 micrograms (mcg) respiratory syncytial virus stabilized prefusion F subunit vaccine (RSVpreF), intramuscularly (IM) on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2023 | May 15, 2026 |
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This is a double-blinded, placebo-controlled study
| Biological |
Placebo |
|
| From vaccination on Day 1 up to 1 month after vaccination |
| Percentage of Maternal Participants With Adverse Event of Special Interest (AESIs) | AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with pregnant maternal participants prior to/during delivery and post delivery. For maternal participants, the following were considered as protocol defined AESIs: diagnosis of Guillain-Barré syndrome; diagnosis of acute polyneuropathy without an underlying etiology; hypertensive disorders of pregnancy; preterm delivery (delivery at <37 0/7 weeks' gestation) and atrial fibrillation. AESIs was to be recorded as an AE or serious adverse event (SAE) on the case report form (CRF). | From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months) |
| Percentage of Maternal Participants With SAEs From Vaccination Throughout the Study | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. | From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months) |
| Percentage of Infant Participants With AESIs From Birth Through 6 Months of Age | AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with infants at birth. For infant participants the following were considered as protocol defined AESIs: preterm birth (born at <37 0/7 week's gestation); birth weight 1001-2500 grams (g); developmental delay. Extremely preterm birth (born at <28 0/7 week's gestation) and extremely low birth weight (less than or equal to [<=] 1000 g) were reported as serious AESIs. | From birth up to 6 months of age |
| Number of Infant Participants With Reported Neonatal Deaths From Birth Through 1 Months of Age | Neonatal death was defined as the death of a live-born infant that occurred within a month after birth. | Within 1 Month after birth |
| Number of Infant Participants With Congenital Malformations/Anomalies at Birth | Congenital malformations/anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. | At birth |
| Number of Infant Participants With Other Neonatal Problems at Birth | Other neonatal problem included dysmaturity, neonatal illness, hospitalization, and drug therapies. | At birth |
| Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth | APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor. | 1 minute after birth |
| Number of Infant Participants According to APGAR Score at 5 Minutes After Birth | APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor. | 5 minutes after birth |
| Number of Infant Participants According to APGAR Score at 10 Minutes After Birth | APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor. | 10 minutes after birth |
| Number of Infant Participants According to Gestational Age (GA) at Birth | GA at birth was collected as:>=24 to <28 weeks, >=28 to <34 weeks, >=34 to <37 weeks, >=37 to <42 weeks, and >=42 weeks. | At birth |
| Number of Infant Participants Requiring Hospitalization at Birth | Length of hospitalization at birth refers to the amount of time the infant remains admitted to the healthcare facility immediately following delivery and if that length of time is greater than or less than 72 hours. Postnatal standard of care procedures in South Africa were as follows: healthy newborns and their mothers were typically discharged within 24 hours after an uncomplicated vaginal delivery, or within 72 hours following an uncomplicated Caesarean section. These practices were supported by the Guidelines for Maternity Care in South Africa. | From birth until discharge from hospitalization (up to a maximum of 72 hours) |
| Percentage of Infant Participants With AEs From Birth to 1 Month of Age | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | From birth to 1 month of age |
| Percentage of Infant Participants With SAEs From Birth Through 6 Months of Age | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. | From birth to 6 months of age |
| Percentage of Infant Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. NDCMCs were reported as both AEs and SAEs. | From birth to 6 months of age |
| Before vaccination on Day 1 and at delivery |
| Geometric Mean Fold Rise (GMFR) of NTs for RSV A and RSV B From Before Vaccination to Delivery: Maternal Participants | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs based on the Student t distribution. The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from the specified time points. | Before vaccination on Day 1 to delivery |
| Bloemfontein |
| Free State |
| 9301 |
| South Africa |
| Worthwhile Clinical Trials | Benoni | Gauteng | 1500 | South Africa |
| REIMED Reiger Park | Boksburg | Gauteng | 1459 | South Africa |
| Wits RHI | Johannesburg | Gauteng | 2001 | South Africa |
| University of Witwatersrand (WITS) - Vaccines and Infectious Diseases Analytics (VIDA) | Johannesburg | Gauteng | 2013 | South Africa |
| Wits VIDA Nkanyezi Research Unit | Johannesburg | Gauteng | 2093 | South Africa |
| Setshaba Research Centre | Pretoria | Gauteng | 0152 | South Africa |
| Botho Ke Bontle Health Services | Pretoria | Gauteng | 0184 | South Africa |
| Qhakaza Mbokodo Research Clinic | Ladysmith | KwaZulu-Natal | 3370 | South Africa |
| Gole Biomed Research Centre | Polokwane | Limpopo | 0699 | South Africa |
| MRC Unit on Child And Adolescent Health | Cape Town | Western Cape | 7700 | South Africa |
| Gugulethu Green Clinic | Cape Town | Western Cape | 7750 | South Africa |
| FAMCRU - Worcester | Worcester | Western Cape | 6850 | South Africa |
| FG001 | Maternal Participants: Placebo | Study-eligible pregnant women (maternal participants) living with HIV were randomized to receive placebo (matching to RSVpreF without active vaccine) IM as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery. |
| FG002 | Infant Participants: RSVpreF | Infant participants born to maternal participants living with HIV who were vaccinated with a single dose of 120 mcg RSVpreF were included. Infant participants were followed from birth up to 6 months of age. |
| FG003 | Infant Participants: Placebo | Infant participants born to maternal participants living with HIV who received placebo (matching RSVpreF without active vaccine) were included. Infant participants were followed from birth up to 6 months of age. |
| Safety Population | Maternal safety population included all randomized maternal participants who received at least 1 dose of the study intervention. Infant safety population included all infant participants who were born to vaccinated maternal participants. |
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| COMPLETED |
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| NOT COMPLETED |
|
|
Maternal safety population included all randomized maternal participants who received at least 1 dose of the study intervention. Infant safety population included all infant participants who were born to vaccinated maternal participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Maternal Participants: RSVpreF | Study-eligible pregnant women (maternal participants) living with HIV were randomized to receive a single dose of 120 mcg RSVpreF, IM on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery. |
| BG001 | Maternal Participants: Placebo | Study-eligible pregnant women (maternal participants) living with HIV were randomized to receive placebo (matching to RSVpreF without active vaccine) IM as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery. |
| BG002 | Infant Participants: RSVpreF | Infant participants born to maternal participants living with HIV who were vaccinated with a single dose of 120 mcg RSVpreF were included. Infant participants were followed from birth up to 6 months of age. |
| BG003 | Infant Participants: Placebo | Infant participants born to maternal participants living with HIV who received placebo (matching RSVpreF without active vaccine) were included. Infant participants were followed from birth up to 6 months of age. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | Percentage of Maternal Participants With Prespecified Local Reactions Within 7 Days After Vaccination | Local reactions included redness, swelling, and pain at injection site and were recorded in electronic diary (e-diary). Redness and swelling were measured by the maternal participant and recorded in measuring device units (mdu) in the e-diary (range: 1 to 21). 1 mdu = 0.5 centimetre (cm). Redness and swelling were graded as mild (>2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm), severe (>10.0 cm) and grade 4 (necrosis or exfoliative dermatitis for redness and necrosis for swelling). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization for severe pain at the injection site). Grade 4 reactions were classified by the investigator or medically qualified designee. | Maternal safety population included all randomized maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants from one of the trial sites were excluded from analysis due to a quality event associated with inappropriate capture of reactogenicity events. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 after vaccination |
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| Primary | Percentage of Maternal Participants With Prespecified Systemic Events Within 7 Days After Vaccination | Systemic events included fever, fatigue, headache, nausea, muscle pain, joint pain, vomiting and diarrhea and were recorded by participants in the e-diary. Fever was defined as an oral temperature greater than or equal to (>=) 38.0 degree Celsius (C) and classified as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C) and grade 4 (>40.0 degree C). Headache, nausea, fatigue, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily activity). Vomiting: mild (1-2 times in 24 hours [H]), moderate (>2 times in 24 H), severe (required intravenous [IV] hydration). Diarrhea: mild (2-3 loose stools in 24 H), moderate (4-5 loose stools in 24 H), severe (>=6 loose stools in 24 H). For all systemic events except fever, Grade 4= emergency room visit or hospitalization. Grade 4 events were classified by investigator or medically qualified designee. | Maternal safety population included all randomized maternal participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants from one of the trial sites were excluded from analysis due to a quality event associated with inappropriate capture of reactogenicity events. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Day 1 to Day 7 after vaccination |
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| Primary | Percentage of Maternal Participants With Adverse Events (AEs) From the Time of Vaccination Through 1 Month After Vaccination | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included in this outcome measure. | Maternal safety population included all randomized maternal participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From vaccination on Day 1 up to 1 month after vaccination |
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| Primary | Percentage of Maternal Participants With Adverse Event of Special Interest (AESIs) | AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with pregnant maternal participants prior to/during delivery and post delivery. For maternal participants, the following were considered as protocol defined AESIs: diagnosis of Guillain-Barré syndrome; diagnosis of acute polyneuropathy without an underlying etiology; hypertensive disorders of pregnancy; preterm delivery (delivery at <37 0/7 weeks' gestation) and atrial fibrillation. AESIs was to be recorded as an AE or serious adverse event (SAE) on the case report form (CRF). | Maternal safety population included all randomized maternal participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months) |
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| Primary | Percentage of Maternal Participants With SAEs From Vaccination Throughout the Study | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. | Maternal safety population included all randomized maternal participants who received at least 1 dose of the study intervention. | Posted | Number | 95% Confidence Interval | Percentage of participants | From vaccination on Day 1 up to 6 months after delivery (up to maximum of 10 months) |
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| Primary | Percentage of Infant Participants With AESIs From Birth Through 6 Months of Age | AESIs are a subset of targeted medical events based on review of known pharmacology, toxicology findings, possible class effects, published literature, and signals arising from safety data assessments, and on population under study. AESIs were based on targeted medical events associated with infants at birth. For infant participants the following were considered as protocol defined AESIs: preterm birth (born at <37 0/7 week's gestation); birth weight 1001-2500 grams (g); developmental delay. Extremely preterm birth (born at <28 0/7 week's gestation) and extremely low birth weight (less than or equal to [<=] 1000 g) were reported as serious AESIs. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From birth up to 6 months of age |
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| Primary | Number of Infant Participants With Reported Neonatal Deaths From Birth Through 1 Months of Age | Neonatal death was defined as the death of a live-born infant that occurred within a month after birth. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Count of Participants | Participants | Within 1 Month after birth |
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| Primary | Number of Infant Participants With Congenital Malformations/Anomalies at Birth | Congenital malformations/anomalies were defined as structural or functional anomalies that occurred during intrauterine life and could be identified prenatally, at birth or later in life. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Count of Participants | Participants | At birth |
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| Primary | Number of Infant Participants With Other Neonatal Problems at Birth | Other neonatal problem included dysmaturity, neonatal illness, hospitalization, and drug therapies. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Count of Participants | Participants | At birth |
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| Primary | Number of Infant Participants According to Appearance, Pulse, Grimace, Activity, and Respiration (APGAR) Score at 1 Minute After Birth | APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor. | Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 1 minute after birth |
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| Primary | Number of Infant Participants According to APGAR Score at 5 Minutes After Birth | APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor. | Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 5 minutes after birth |
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| Primary | Number of Infant Participants According to APGAR Score at 10 Minutes After Birth | APGAR was a fast evaluation technique used to evaluate a newborn baby's overall health. APGAR stands for (A) Appearance (skin coloration), (P) Pulse (heart rate), (G) Grimace (reflex response), (A) Activity (muscle tone) and (R) Respiration (breathing). Each component was given a score of 0, 1, or 2; after summing up scores for each component a total possible score was of 0 (worst condition) to 10 (best condition), where higher scores indicate better health. A score of 7 to 10 was good, 4 to <7 was moderate, and <4 was poor. | Infant safety population included all infant participants who were born to vaccinated maternal participants. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 10 minutes after birth |
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| Primary | Number of Infant Participants According to Gestational Age (GA) at Birth | GA at birth was collected as:>=24 to <28 weeks, >=28 to <34 weeks, >=34 to <37 weeks, >=37 to <42 weeks, and >=42 weeks. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Count of Participants | Participants | At birth |
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| Primary | Number of Infant Participants Requiring Hospitalization at Birth | Length of hospitalization at birth refers to the amount of time the infant remains admitted to the healthcare facility immediately following delivery and if that length of time is greater than or less than 72 hours. Postnatal standard of care procedures in South Africa were as follows: healthy newborns and their mothers were typically discharged within 24 hours after an uncomplicated vaginal delivery, or within 72 hours following an uncomplicated Caesarean section. These practices were supported by the Guidelines for Maternity Care in South Africa. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Count of Participants | Participants | From birth until discharge from hospitalization (up to a maximum of 72 hours) |
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| Primary | Percentage of Infant Participants With AEs From Birth to 1 Month of Age | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From birth to 1 month of age |
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| Primary | Percentage of Infant Participants With SAEs From Birth Through 6 Months of Age | An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence that at any dose: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or that was considered an important medical event. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From birth to 6 months of age |
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| Primary | Percentage of Infant Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Birth Through 6 Months of Age | An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects. NDCMCs were reported as both AEs and SAEs. | Infant safety population included all infant participants who were born to vaccinated maternal participants. | Posted | Number | 95% Confidence Interval | Percentage of participants | From birth to 6 months of age |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Titer (GMT) of Neutralizing Titer (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) and Respiratory Syncytial Virus Subgroup B (RSV B) Before Vaccination and at Delivery: Maternal Participants | GMTs and the corresponding 2-sided 95% confidence intervals (CIs) were calculated by exponentiating the mean logarithm of the neutralizing titers and the corresponding CIs based on the Student t distribution. | All maternal participants who were eligible, received the study intervention to which they were randomized, had blood drawn for assay testing within the specified time frame, had valid and determinate assay results for the proposed analysis, and had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants from one of the trial sites were excluded from analysis due to a critical quality event. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Before vaccination on Day 1 and at delivery |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Fold Rise (GMFR) of NTs for RSV A and RSV B From Before Vaccination to Delivery: Maternal Participants | GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the fold rises and the corresponding CIs based on the Student t distribution. The GMFR for each vaccine group was defined as the geometric mean of the fold rises in the assay results from the specified time points. | All maternal participants who were eligible, received the study intervention to which they were randomized, had blood drawn for assay testing within the specified time frame, had valid and determinate assay results for the proposed analysis, and had no major protocol violations. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. Participants from one of the trial sites were excluded from analysis due to a critical quality event. | Posted | Geometric Mean | 95% Confidence Interval | Fold rise | Before vaccination on Day 1 to delivery |
|
Maternal participants: Local reactions and systemic events: From Day 1 to Day 7 after vaccination; SAEs and AESIs: From vaccination on Day 1 up to 6 months after delivery (maximum up to 10 months); Other AEs: From vaccination on Day 1 up to 1 month after vaccination; Infant participants: SAEs, AESIs and NDCMCs: From birth up to 6 months of age; Other AEs: From birth up to 1 month
Local reactions and systemic events were assessed by systematic assessment; AEs by non-systematic assessment. Same event may appear as both an SAE and non-SAE. But what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both SAE and non-SAE. Maternal and infant safety population was evaluated. NDCMCs were reported as both AEs and SAEs.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Maternal Participants: RSVpreF | Study-eligible pregnant women (maternal participants) living with HIV were randomized to receive a single dose of 120 mcg RSVpreF, IM on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery. | 1 | 172 | 60 | 172 | 103 | 172 |
| EG001 | Maternal Participants: Placebo | Study-eligible pregnant women (maternal participants) living with HIV were randomized to receive placebo (matching to RSVpreF without active vaccine) IM as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery. | 2 | 170 | 57 | 170 | 115 | 170 |
| EG002 | Infant Participants: RSVpreF | Infant participants born to maternal participants living with HIV who were vaccinated with a single dose of 120 mcg RSVpreF were included. Infant participants were followed from birth up to 6 months of age. | 1 | 171 | 32 | 171 | 53 | 171 |
| EG003 | Infant Participants: Placebo | Infant participants born to maternal participants living with HIV who received placebo (matching RSVpreF without active vaccine) were included. Infant participants were followed from birth up to 6 months of age. | 3 | 166 | 36 | 166 | 52 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Anaemia neonatal | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Anaemia of pregnancy | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cardiac arrest neonatal | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Tachycardia foetal | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cleft lip | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Congenital haematological disorder | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Congenital hydrocephalus | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Congenital pneumonia | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Foetal alcohol syndrome | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Microcephaly | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Polydactyly | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pulmonary artery stenosis congenital | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Talipes | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Trisomy 13 | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Trisomy 18 | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Trisomy 21 | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Primary hypoparathyroidism | Endocrine disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Necrotising colitis | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Amniotic cavity infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cervicitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Meningitis tuberculous | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neonatal pneumonia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bladder injury | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Endotracheal intubation complication | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| HIV test positive | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Feeding disorder | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypoglycaemia neonatal | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bone metabolism disorder | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Encephalopathy neonatal | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hydrocephalus | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Arrested labour | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Breech presentation | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cephalo-pelvic disproportion | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Failed induction of labour | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Failed trial of labour | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| False labour | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Foetal hypokinesia | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Foetal macrosomia | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gestational diabetes | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Haemorrhage in pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Obstructed labour | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Postpartum haemorrhage | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Premature separation of placenta | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Preterm premature rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Prolonged labour | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Prolonged pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Prolonged rupture of membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Retained placenta or membranes | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Uterine scar | Reproductive system and breast disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cyanosis central | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cyanosis neonatal | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Infantile apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Meconium aspiration syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neonatal hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neonatal respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neonatal respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Victim of homicide | Social circumstances | MedDRA v28.0 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Anaemia of pregnancy | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Thrombocytopenia neonatal | Blood and lymphatic system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neonatal tachycardia | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Tachycardia foetal | Cardiac disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Congenital syphilis | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Congenital umbilical hernia | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Tethered oral tissue | Congenital, familial and genetic disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Retinopathy of prematurity | Eye disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Developmental delay | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Diarrhoea (DIARRHEA) | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Nausea (NAUSEA) | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Tongue geographic | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vomiting (VOMITING) | Gastrointestinal disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Body tinea | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pustule | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Sepsis neonatal | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Toxoplasmosis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Perineal injury | Injury, poisoning and procedural complications | MedDRA v28.0 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| HIV test positive | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Herpes simplex test positive | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v28.0 | Non-systematic Assessment |
| |
| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Underweight | Metabolism and nutrition disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Growth retardation | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Ligament pain | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Intraventricular haemorrhage | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neonatal seizure | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Nystagmus | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Foetal growth restriction | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Jaundice neonatal | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Large for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Low birth weight baby | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Premature baby | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Small for dates baby | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Umbilical granuloma | Pregnancy, puerperium and perinatal conditions | MedDRA v28.0 | Non-systematic Assessment |
| |
| Leukocyturia | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Galactorrhoea | Reproductive system and breast disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Meconium aspiration syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Neonatal respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Transient tachypnoea of the newborn | Respiratory, thoracic and mediastinal disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Erythema toxicum neonatorum | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v28.0 | Non-systematic Assessment |
| |
| Injection site pain (PAIN AT INJECTION SITE) | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Swelling (SWELLING) | General disorders | MedDRA v28.0 | Systematic Assessment |
| |
| Erythema (REDNESS) | Skin and subcutaneous tissue disorders | MedDRA v28.0 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov.Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 21, 2024 | May 15, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Between 16 and 44 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Redness: Moderate |
|
| Redness: Severe |
|
| Swelling: Any |
|
| Swelling: Mild |
|
| Swelling: Moderate |
|
| Swelling: Severe |
|
| Pain at injection site: Any |
|
| Pain at injection site: Mild |
|
| Pain at injection site: Moderate |
|
| Pain at injection site: Severe |
|
| OG001 | Maternal Participants: Placebo | Study-eligible pregnant women (maternal participants) living with HIV were randomized to receive placebo (matching to RSVpreF without active vaccine) IM as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery. |
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| Units | Counts |
|---|---|
| Participants |
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Study-eligible pregnant women (maternal participants) living with HIV were randomized to receive placebo (matching to RSVpreF without active vaccine) IM as a single dose on Day 1 (day of vaccination). Participants were followed up to 6 months after delivery.
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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