A Phase 4 interventional study of Rotarix vaccine and measles-rubella vaccine in Measles Antibody Seroconversion, Rubella Antibody Seroconversion and Rotavirus Geometric Mean Titer (GMT), sponsored by PATH. Completed at 1 site in Bangladesh. Open to participants aged 9 Months to 11 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-13.
Sponsored by PATH · Phase 4, Interventional, and Prevention
The investigators aim to establish the non-inferiority of concomitant administration of measles-rubella and rotavirus vaccines to measles-rubella vaccine given alone in terms of measles seroconversion rates. The primary study hypothesis is the measles seroconversion rate as defined by the percentage of children seroconverting to measles with a measles serum antibody concentration of >=1:120 at 8 weeks post vaccination after the concomitant administration of measles-rubella and rotavirus vaccines is non-inferior to that obtained when measles-rubella vaccine is given alone in children 9 months of age who have received a primary rotavirus vaccine series with the first dose between 6 and 10 weeks and the second at least 4 weeks later and are seronegative for measles antibody in the pre-vaccination sample.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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Hypersensitivity
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Investigational drug or device
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine and one 1.0 ml dose of oral Rotarix vaccine at 9 months of age
Biological: Rotarix vaccine · Biological: measles-rubella vaccine
receive one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine at 9 months of age
Biological: measles-rubella vaccine
one 1.0 ml dose of oral rotavirus vaccine at 9 months of age
Also known as: rotavirus vaccine
one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
Also known as: Measles-Rubella Virus Vaccine Live US Pharmacopeia (USP)
Percentage/Number of Subjects With Seroprotection for Measles Virus Serum Neutralization Antibodies
Detected by plaque reduction neutralization test (PRNT). Seroprotection defined as measles serum antibody concentration \>=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 \< 1/8; this was the lowest dilution at which sera were tested.
Time frame: 8 weeks post vaccination
Percentage/Number of Subjects With Seroprotection for Anti-measles Virus Immunoglobulin G (IgG)
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
Time frame: 8 weeks post vaccination
Percentage/Number of Subjects With Seroconversion for Anti-rubella Virus Immunoglobulin G (IgG)
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
Time frame: 8 weeks post vaccination
Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG)
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
Time frame: 8 weeks post vaccination
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin A (IgA)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin A (IgA)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of \<20 U/mL are converted to 10 U/mL for calculation purposes.
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Percentage/Number of Subjects Seropositive for Anti-rotavirus Immunoglobulin G (IgG)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Geometric Mean Titer (GMT) of Anti-rotavirus Immunoglobulin G (IgG)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of \<20 U/mL are converted to 10 U/mL for calculation purposes.
Time frame: Visit 1 (pre-vaccination) and 8 weeks post vaccination
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin A (IgA)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Time frame: 8 weeks post vaccination
Percentage/Number of Subjects With Seroconversion for Anti-rotavirus Immunoglobulin G (IgG)
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
Time frame: 8 weeks post vaccination
Number/Percentage of Subjects Experiencing Immediate Post-vaccination Reactions Following Administration of Vaccine
Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.
Time frame: 30 minutes post-vaccination
Number/Percentage of Subjects Experiencing Solicited Adverse Events
Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.
Time frame: 14 days post-vaccination
Number/Percentage of Subjects Experiencing Unsolicited Non-serious Adverse Events
Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.
Time frame: 14 days post-vaccination
Number/Percentage of Subjects Experiencing Serious Adverse Events
An adverse event (AE) or suspected AE was considered "serious" if it resulted in any of the following outcomes: * Death * A life-threatening AE (the term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time frame: 2 months after vaccination
Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies
Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method \[12\]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.
Time frame: 8 weeks post vaccination
Number of Participants With Rotavirus Vaccine Shedding
Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).
Time frame: Day 0, Day 4 and Day 7
Study population was drawn from participants living in the International Center for Diarrheal Disease Research, Bangladesh (icddr,b) service area of Matlab, Bangladesh.
| Milestone | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Started | 240 | 240 |
| Completed | 240 | 240 |
| Not completed | 0 | 0 |
| Milestone | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Started | 240 | 240 |
| Completed | 227 | 233 |
| Not completed | 13 | 7 |
| Withdrew: Lost to follow-up | 7 | 4 |
| Withdrew: Protocol violation | 5 | 1 |
| Withdrew: Baseline measles measure high | 1 | 2 |
Detected by plaque reduction neutralization test (PRNT). Seroprotection defined as measles serum antibody concentration \>=1:120 8 weeks post vaccination. Assays were standardized using WHO Second International Standard for measles antibody containing 5000 mIU/ml, which enables the 50% neutralizing antibody end-point dose (titer, ND50) of test samples to be transformed to antibody concentrations in terms of mIU/ml. The analytical cut-off value in this assay was ND50 \< 1/8; this was the lowest dilution at which sera were tested.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Seroprotection | 171 | 173 |
| No seroprotection | 56 | 60 |
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for measles virus. All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Seroprotection | 219 | 227 |
| No seroprotection | 8 | 5 |
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Seroprotection | 228 | 233 |
| No seroprotection | 0 | 1 |
Used commercially available indirect enzyme-linked IgG immunoassays (EIAs; Wampole Laboratories, Princeton, New Jersey). An index standard ratio (ISR) of ≥1.10 on both runs of the respective assay was considered evidence of seropositivity for rubella virus. An ISR of at least 1.10 represents 10 IU/mL of rubella virus antibody, consistent with a protective level.All measles virus and rubella virus assays were performed at the National Measles and Rubella Reference Laboratories, Measles, Mumps, Rubella, and Herpesviruses Branch, Division of Viral Diseases, Centers for Disease Control and Prevention (Atlanta, Georgia).
| IU/mL | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Geometric Mean Concentration (GMC) for Anti-rubella Virus Immunoglobulin G (IgG) | 191.9 (174.8 to 210.7) | 177.8 (161.8 to 195.4) |
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
| Participants | Measles-rubella and Rotavirus Vaccine | Measles-rubella Vaccine |
|---|---|---|
| Pre-vaccination — Seropositive | 126 | 113 |
| Pre-vaccination — Not seropositive | 113 | 127 |
| Post-vaccination — Seropositive | 160 | 110 |
| Post-vaccination — Not seropositive | 70 | 130 |
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of \<20 U/mL are converted to 10 U/mL for calculation purposes.
| U/mL | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Pre-vaccination | 43.6 (34.8 to 54.5) | 39.2 (31.3 to 49.1) |
| Post-vaccination | 60.6 (49.4 to 74.2) | 38.1 (30.5 to 47.6) |
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Pre-vaccination — Seropositive | 159 | 140 |
| Pre-vaccination — Not seropositive | 81 | 100 |
| Post-vaccination — Seropositive | 204 | 135 |
| Post-vaccination — Not seropositive | 27 | 101 |
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. Rotavirus IgA and IgG values of \<20 U/mL are converted to 10 U/mL for calculation purposes.
| U/mL | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Pre-vaccination | 79.2 (61.4 to 102.1) | 63.2 (49.1 to 81.4) |
| Post-vaccination | 168.6 (137.3 to 207.2) | 60.1 (46.7 to 77.5) |
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Seroconversion | 48 | 8 |
| No seroconversion | 62 | 118 |
Antirotavirus immunoglobulin A (IgA) and IgG were measured by enzyme-linked immunosorbent assay at the Laboratory of Specialized Clinical Studies at the Cincinnati Children's Hospital Medical Center (Cincinnati, Ohio). A standard serum pool was used to determine arbitrary units of rotavirus IgA or IgG in each sample. A subject was considered seropositive if the IgA or IgG rotavirus antibody concentration was ≥20 U/mL.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Seroconversion | 55 | 7 |
| No seroconversion | 25 | 92 |
Immediate reactogenicity was defined as local or systemic reactions occurring directly and up to 30 minutes after vaccine receipt, with an emphasis on allergic reactions.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Any immediate reaction | 0 | 0 |
| No immediate reaction | 240 | 240 |
Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. They included diarrhea, fever, vomiting, loss of appetite, irritability, and intussusception. Adverse events were graded for severity and relationship to vaccine.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Grade 1: unrelated to vaccine | 25 | 34 |
| Grade 2: unrelated to vaccine | 4 | 4 |
| Grade 3: unrelated to vaccine | 2 | 0 |
| None | 209 | 202 |
Solicited non-serious adverse events were collected based on recall at study visits 2 (Day 4) through 5 (Day 14) following administration of Rotarix® vaccine. Adverse events were graded for severity and relationship to vaccine.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Related to vaccine | 0 | 0 |
| Unrelated to vaccine | 63 | 68 |
| No unsolicited non-serious adverse event | 177 | 172 |
An adverse event (AE) or suspected AE was considered "serious" if it resulted in any of the following outcomes: * Death * A life-threatening AE (the term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions Important medical events that may not result in death, be life threatening, or require hospitalization would have been considered severe adverse events when, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed in this definition.
| Participants | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Any serious adverse event, unrelated to vaccine | 10 | 6 |
| No serious adverse event | 230 | 234 |
Sera were analyzed for the presence of measles virus serum neutralizing antibodies (SNAs), using a standardized plaque reduction neutralization (PRN) assay, in which PRN titers, defined as the serum dilutions that reduced the number of plaques by 50%, were calculated using the Kärber method \[12\]. A 1:100 dilution of World Health Organization (WHO) Second International Standard Anti-Measles Serum (IS, coded 66/202, supplied by the National Institute for Biological Standards and Control, South Mimms, United Kingdom) was tested in parallel with each serum specimen to calculate the reciprocal of the 50% end point titer determined by the PRN test.
| mIU/mL | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Geometric Mean Concentration (GMC) for Measles Virus Serum Neutralization Antibodies | 196.3 (175.3 to 219.7) | 194.2 (174.0 to 216.7) |
Based on 5 grams of stool sample. Vaccine shedding defined as presence of vaccine-type rotavirus in stool at 4 (+/-1) and/or 7 (+/-1) days post rotavirus vaccination detected by enzyme-linked immunosorbent assay (ELISA) and typed by reverse-transcriptase polymerase chain reaction (RT-PCR).
| Participants | Measles-rubella and Rotavirus Vaccines |
|---|---|
| Day 0 — Negative | 140 |
| Day 0 — Positive | 0 |
| Day 0 — No stool | 100 |
| Day 4 — Negative | 234 |
| Day 4 — Positive | 4 |
| Day 4 — No stool | 2 |
| Day 7 — Negative | 234 |
| Day 7 — Positive | 6 |
| Day 7 — No stool | 0 |
Collected over 2 months after vaccination. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Measles-rubella and Rotavirus Vaccines | 0/240 (0%) | 10/240 (4.2%) | 63/240 (26.3%) |
| Measles-rubella Vaccine | 0/240 (0%) | 6/240 (2.5%) | 68/240 (28.3%) |
| Event | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| Acute watery diarrheaGastrointestinal disorders | 4/240 | 3/240 |
| Urinary tract infectionInfections and infestations | 2/240 | 0/240 |
| Acute bronchiolitisInfections and infestations | 1/240 | 1/240 |
| Acute nasopharyngitisRespiratory, thoracic and mediastinal disorders | 1/240 | 0/240 |
| Febrile convulsionNervous system disorders | 0/240 | 1/240 |
| PneumoniaInfections and infestations | 1/240 | 0/240 |
| Pneumonia with UTIInfections and infestations | 1/240 | 0/240 |
| Severe pneumoniaInfections and infestations | 0/240 | 1/240 |
| Event | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine |
|---|---|---|
| NasopharyngitisRespiratory, thoracic and mediastinal disorders | 32/240 | 38/240 |
| Respiratory tract infectionInfections and infestations | 16/240 | 13/240 |
| DysenteryGastrointestinal disorders | 9/240 | 12/240 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/240 | 4/240 |
| Otitis media chronicInfections and infestations | 3/240 | 0/240 |
| Fungal infectionInfections and infestations | 2/240 | 1/240 |
| Abdominal distensionGastrointestinal disorders | 0/240 | 1/240 |
| ConjunctivitisInfections and infestations | 0/240 | 1/240 |
| Ear painEar and labyrinth disorders | 1/240 | 0/240 |
| Mouth ulcerationGastrointestinal disorders | 1/240 | 0/240 |
| Age, Continuous(months) | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine | Total |
|---|---|---|---|
| Mean | 9.38 ± 0.252 | 9.39 ± 0.254 | 9.38 ± 0.253 |
| Sex: Female, Male(Participants) | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine | Total |
|---|---|---|---|
| Female | 110 | 123 | 233 |
| Male | 130 | 117 | 247 |
| Currently breastfed(Participants) | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine | Total |
|---|---|---|---|
| Yes | 236 | 238 | 474 |
| No | 4 | 2 | 6 |
| Length(cm) | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine | Total |
|---|---|---|---|
| Mean | 69.56 ± 2.488 | 69.81 ± 2.786 | 69.68 ± 2.642 |
| Weight(kilograms) | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine | Total |
|---|---|---|---|
| Mean | 8.01 ± 1.101 | 7.97 ± 0.933 | 7.99 ± 1.047 |
| Mother's age(years) | Measles-rubella and Rotavirus Vaccines | Measles-rubella Vaccine | Total |
|---|---|---|---|
| Mean | 27.1 ± 5.84 | 26.7 ± 5.90 | 26.9 ± 5.87 |
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