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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.
Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. This randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen | Active Comparator | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. |
|
| Placebo | Placebo Comparator | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fever >=38C Within 32 Hours of Vaccination. | Fever, defined as rectal temperature >=38C within 32 hours of vaccination. | Fever within 32 hours following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Fever >=39C Within 32 Hours of Vaccination. | Fever, defined as rectal temperature >=39C within 32 hours of vaccination. | Fever within 32 hours following vaccination |
| Study Assignment Unblinded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa A Jackson, MD, MPH | Kaiser Permanente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Group Health Research Institute | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21698100 | Result | Jackson LA, Peterson D, Dunn J, Hambidge SJ, Dunstan M, Starkovich P, Yu O, Benoit J, Dominguez-Islas CP, Carste B, Benson P, Nelson JC. A randomized placebo-controlled trial of acetaminophen for prevention of post-vaccination fever in infants. PLoS One. 2011;6(6):e20102. doi: 10.1371/journal.pone.0020102. Epub 2011 Jun 17. |
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No significant events followed participant enrollment prior to group assignment.
Recruitment and enrollment took place between May 2006 and September 2009. Children potentially eligible for study participation were identified from the Group Health data systems and parents were mailed a letter providing information on the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acetaminophen | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose. |
| FG001 | Placebo | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who did not receive acetaminophen or placebo due to postal problems (3), who were not given a first dose of acetaminophen or placebo (13) or who were lost to follow-up due to study diary not being returned (6) were not included in analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acetaminophen | Subjects who were randomized to receive acetaminophen |
| BG001 | Placebo | Subjects who were randomized to receive placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fever >=38C Within 32 Hours of Vaccination. | Fever, defined as rectal temperature >=38C within 32 hours of vaccination. | Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group. | Posted | Number | percentage of participants | Fever within 32 hours following vaccination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acetaminophen | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Jackson, MD, MPH | Group Health Research Institute | 206-442-5216 | jackson.L@ghc.org |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| placebo | Other | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. |
|
The need for unblinding at any time during the study
| At any time during participation in the study |
| Medical Utilization | Telephone calls to the consulting nurse or the child's physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination. | Within 32 hours of vaccination. |
| Infant Fussiness | Parents were asked to record level of fussiness (compared with the child's usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual. | Within 32 hours of vaccination |
| Parent Time Lost From Sleep | Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night. | On the night following vaccinations |
| Infant Time Lost From Sleep | Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night. | On the night following vaccinations |
| Parent Time Lost From Work | Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days. | Through the day after vaccination |
| Lost to Follow-up |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Fever >=39C Within 32 Hours of Vaccination. | Fever, defined as rectal temperature >=39C within 32 hours of vaccination. | Temperature values were missing for one subject in the acetaminophen group and two subjects in the placebo group. | Posted | Number | percentage of participants | Fever within 32 hours following vaccination |
|
|
|
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| Secondary | Study Assignment Unblinded | The need for unblinding at any time during the study | Posted | Number | percentage of participants | At any time during participation in the study |
|
|
|
|
| Secondary | Medical Utilization | Telephone calls to the consulting nurse or the child's physician that were made due to concerns regarding an acute illness, fever, or possible vaccine reaction and outpatient, urgent care, and emergency room visits that were for evaluation of an acute illness, fever, or a possible vaccine reaction, within 32 hours of vaccination. | Posted | Number | percentage of participants | Within 32 hours of vaccination. |
|
|
|
|
| Secondary | Infant Fussiness | Parents were asked to record level of fussiness (compared with the child's usual) within 32 hours of vaccination, using the categories much less than usual, less than usual, about usual, more than usual, and much more than usual. | Posted | Number | percentage of participants | Within 32 hours of vaccination |
|
|
|
|
| Secondary | Parent Time Lost From Sleep | Parents were asked about their sleep on the night following the vaccinations. They were asked to report whether they slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night. | Posted | Number | percentage of participants | On the night following vaccinations |
|
|
|
|
| Secondary | Infant Time Lost From Sleep | Parents were asked about their infant's sleep on the night following the vaccinations. They were asked to report whether their infant slept much less than usual, less than usual, about the usual amount, more than usual, or much more than usual on that night. | Posted | Number | percentage of participants | On the night following vaccinations |
|
|
|
|
| Secondary | Parent Time Lost From Work | Parents were asked to report whether they were scheduled to work on the day of the vaccination visit (but following that visit) or the next day and, if so, whether they had to miss work to care for their infant because of fever, fussiness, or possible vaccine reaction on those days. | Refers to the number of participants for whom parents reported that they were scheduled to work on the day of the vaccination visit or the day following the child's vaccination visit. | Posted | Number | percentage of participants | Through the day after vaccination |
|
|
|
|
| 0 |
| 176 |
| 0 |
| 176 |
| EG001 | Placebo | Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child's weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. | 0 | 176 | 0 | 176 |
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| Aniline Compounds |
| D000588 | Amines |
| Infant fussiness-Much more than usual |
|
| Parent sleep - Much less than usual |
|
| Infant sleep - Much less than usual |
|