Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004_078 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
Not provided
Not provided
Not provided
Not provided
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Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RotaTeqâ„¢ Lot 1 | Experimental | ~8.81 X 10^7 IU/Dose of RotaTeqâ„¢ |
|
| RotaTeqâ„¢ Lot 2 | Experimental | ~8.01 X 10^7 IU/Dose of RotaTeqâ„¢ |
|
| RotaTeqâ„¢ Lot 3 | Experimental | ~6.91 X 10^7 IU/Dose of RotaTeqâ„¢ |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rotavirus vaccine, live, oral, pentavalent | Biological | Three oral doses (~8.81 X 10^7 IU/Dose for Lot 1; ~8.01 X 10^7 IU/Dose for Lot 2; and ~6.91 X 10^7 IU/Dose for Lot 3) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | Antibody response to 3 manufactured lots of RotaTeqâ„¢ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8] | 42 days following the 3rd vaccination |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). | Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA | 42 days following the 3rd vaccination |
| Number of Subjects With Clinical Adverse Experiences (CAEs) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
Subjects with prior rotavirus disease, chronic diarrhea, and fever at time of immunization were excluded
from the trial.
The study was conducted at 10 sites in the United States from 09-May-2003 (first patient in) to 02-Jul-2004
(last dose given).
Last subject completed follow-up: 13-Aug-2004.
All data corrections applied (Frozen File) date: 30-Sep-2004
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RotaTeqâ„¢ Lot 1 | Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| FG001 | RotaTeqâ„¢ Lot 2 | Three oral doses (~8.01 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| FG002 | RotaTeqâ„¢ Lot 3 | Three oral doses (~6.91 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| FG003 | Placebo | Placebo-matching RotaTeqâ„¢ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RotaTeqâ„¢ Lot 1 | Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| BG001 | RotaTeqâ„¢ Lot 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | Antibody response to 3 manufactured lots of RotaTeqâ„¢ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A[8] | Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations. | Posted | Geometric Mean | 95% Confidence Interval | dilution units | 42 days following the 3rd vaccination |
|
Patients in this study were followed for all adverse experiences, for up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first.
The number of patients listed in the Adverse Event tables (226 - Lot 1, 224 - Lot 2, 229 - Lot 3, and 112 - Placebo) is the number of patients who received study treatment.
Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
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 | RotaTeqâ„¢ Lot 1 | Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Congenital ventricular septal defect | Congenital, familial and genetic disorders | MedDRA (7.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA (7.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
Not provided
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| C492535 | RotaTeq |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Placebo | Biological | Placebo-matching RotaTeqâ„¢ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination |
|
Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
| Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment. | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Number of Subjects Discontinued Due to Clinical Adverse Experiences | A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment. | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Moved |
|
| Other |
|
Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| BG002 | RotaTeqâ„¢ Lot 3 | Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| BG003 | Placebo | Placebo-matching RotaTeqâ„¢ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| BG004 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| OG001 |
| RotaTeqâ„¢ Lot 2 |
Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| OG002 | RotaTeqâ„¢ Lot 3 | Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
| OG003 | Placebo | Placebo-matching RotaTeqâ„¢ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. |
|
|
|
| Other Pre-specified | Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). | Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA | Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations. | Posted | Geometric Mean | 95% Confidence Interval | units/mL | 42 days following the 3rd vaccination |
|
|
|
| Other Pre-specified | Number of Subjects With Clinical Adverse Experiences (CAEs) | Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | Safety Population: All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| Other Pre-specified | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. | All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| Other Pre-specified | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment. | All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| Other Pre-specified | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose | All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| Other Pre-specified | Number of Subjects Discontinued Due to Clinical Adverse Experiences | A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. | All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| Other Pre-specified | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment. | All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| Other Pre-specified | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. | All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| Other Pre-specified | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. | All subjects who were vaccinated and followed up | Posted | Number | Participants | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first |
|
|
|
| 4 |
| 226 |
| 206 |
| 226 |
| EG001 | RotaTeqâ„¢ Lot 2 | Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. | 4 | 224 | 212 | 224 |
| EG002 | RotaTeqâ„¢ Lot 3 | Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeqâ„¢ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. | 2 | 229 | 211 | 229 |
| EG003 | Placebo | Placebo-matching RotaTeqâ„¢ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. | 3 | 111 | 101 | 111 |
| Constipation | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Pneumonia viral | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Dacryostenosis acquired | Eye disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Infantile colic | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Regurgitation of food | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Teething | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Injection site discomfort | General disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Candida nappy rash | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Croup infectious | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Eye infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Viral rash | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (7.0) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Crying | Psychiatric disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (7.0) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (7.0) | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Without CAEs |
|
| Without Serious CAEs |
|
| Without vaccine-related CAEs |
|
| Without serious vaccine-related CAEs |
|
| Not discontinued due to CAEs |
|
| Not discontinued due to vaccine-related CAEs |
|
| Not discontinued due to serious CAEs |
|
| NOTdiscontinued dueto serious vaccine-related CAEs |
|