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Acthib

Last reviewed on RxList: 12/2/2020
Acthib Side Effects Center

What Is ActHIB?

ActHIB (haemophilus b conjugate vaccine) is an immunization used to prevent infection caused by haemophilus B bacteria, and is sometimes combined with vaccines to protect against other diseases. ActHIB vaccine will not protect against other types of influenza.

What Are Side Effects of ActHIB?

Common side effects of ActHIB include

  • injection site reactions (redness, pain, swelling, or a lump)
  • low fever
  • mild fussiness or crying
  • joint pain
  • body aches
  • drowsiness, or
  • diarrhea

Dosage for ActHIB

The number of doses of ActHIB Vaccine indicated depends on the age at which immunization is begun. A child 7 to 11 months of age should receive 2 doses of ActHIB Vaccine at 8-week intervals and a booster dose at 15 to 18 months of age. A child 12 to 14 months of age should receive 1 dose of ActHIB Vaccine followed by a booster 2 months later. Consult your doctor for the immunization schedule.

What Drugs, Substances, or Supplements Interact with ActHIB?

ActHIB may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications and supplements you use, and all vaccines you have recently received.

ActHIB During Pregnancy and Breastfeeding

Before you receive the ActHIB vaccine, tell your doctor if you are pregnant. This vaccine should not be given to a woman who is breastfeeding.

Additional Information

Our ActHIB (haemophilus b conjugate vaccine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Acthib Consumer Information

Get emergency medical help if your child has signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with haemophilus B is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Call your doctor at once if your child has:

  • fussiness, irritability, crying for an hour or longer; or
  • high fever (within a few hours or a few days after the vaccine).

Common side effects may include:

  • vomiting, loss of appetite;
  • diarrhea; or
  • pain, swelling, or redness where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the entire detailed patient monograph for Acthib (Haemophilus b Conjugate Vaccine)

Acthib Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

More than 7,000 infants and young children (≤2 years of age) have received at least one dose of ActHIB vaccine during US clinical trials. Of these, 1,064 subjects 12 to 24 months of age who received ActHIB vaccine alone reported no serious or life threatening adverse reactions.(1) (2)

Adverse reactions associated with ActHIB vaccine generally subsided after 24 hours and did not persist beyond 48 hours after immunization.

In a US trial, the safety of ActHIB vaccine was evaluated in 110 children 15 to 20 months of age. All children received three doses of Haemophilus influenzae type b conjugate vaccine (ActHIB vaccine or a previously licensed Haemophilus b conjugate vaccine) at approximately 2, 4, and 6 months of age. The incidence of selected solicited injection site and systemic adverse reactions which occurred within 48 hours following the dose of ActHIB vaccine is shown in Table 1.

Table 1: Local and Systemic Reactions at 6, 24, and 48 Hours Following Immunization with ActHIB Vaccine in Children 15 to 20 months old (2)

Adverse Event6 Hrs. Post-dose24 Hrs. Post-dose48 Hrs. Post-dose
Local (%)N=110N=110N=110
Tenderness20.08.20.9
Erythema (>1”)0.00.90.0
Induration*5.53.60.9
Swelling3.61.80.0
Systemic (%)N=103-110N=105-110N=104-110
Fever
(>102.2°F)
(>39.0°C)
01.01.9
Irritability27.320.912.7
Drowsiness36.417.312.7
Adverse Event6 Hrs. Post-dose24 Hrs. Post-dose48 Hrs. Post-dose
Anorexia12.710.06.4
Vomiting0.90.90.9
Persistent cry000
Unusual cry000
*Induration is defined as hardness with or without swelling.

In a US clinical trial (P3T06), 1,454 children were enrolled and received one dose of ActHIB vaccine at 2 months of age and subsequent doses administered at 4 and 6 months of age (concomitantly with DAPTACEL [a US-licensed diphtheria, tetanus and pertussis vaccine], IPOL [a US-licensed inactivated poliovirus vaccine] and PCV7 [Pneumococcal conjugate vaccine, 7-valent]) vaccines at 2, 4, and 6 months of age and hepatitis B vaccine at 2 and 6 months of age). At 15-16 months of age, 418 children received a 4th dose of ActHIB and DAPTACEL vaccines. The most frequent systemic reactions following any dose (>50% of participants) were decreased activity/lethargy, fussiness/irritability, and inconsolable crying.

Table 2: Number (Percentage) of Children with Selected Solicited Systemic Adverse Reactions by Severity Occurring within 0-3 days After Vaccination in Study P3T06

Systemic ReactionsDAPTACEL + IPOL + ActHIB VaccinesDAPTACEL + ActHIB Vaccines
Dose 1
N=1,390-1,406 %
Dose 2
N=1,346-1,360 %
Dose 3
N=1,301-1,312 %
Dose 4
N=379-381 %
Fever*†
≥38.0°C9.316.115.88.7
>38.5°C1.64.35.13.2
>39.5°C0.10.40.30.8
Decreased Activity/Lethargy‡
Any51.137.433.224.1
Moderate or Severe24.315.812.79.2
Severe1.21.40.60.3
Inconsolable Crying
Any58.551.447.936.2
≥1 hour16.416.012.210.5
>3 hours2.23.41.41.8
Fussiness/Irritability
Any75.870.767.153.8
≥1 hour33.330.526.219.4
>3 hours5.65.54.34.5
Note. - Ages of study participants ranged from 1.3 to 19.5 months.
*Fever is based upon actual temperatures recorded with no adjustments to the measurement route.
†Following Doses 1-3 combined, the proportion of temperature measurements that were taken by axillary, rectal or other routes, or not recorded were 44.8%, 54.0%, 1.0%, and 0.1%, respectively. Following Dose 4, the proportion of temperature measurements that were taken by axillary, rectal or other routes, or not recorded were 61.1%, 36.6%, 1.7%, and 0.5%, respectively.
‡Moderate: interferes with or limits usual daily activity; Severe: disabling, not interested in usual daily activity.

In Study P3T06, within 30 days following any of Doses 1-3 of DAPTACEL + IPOL + ActHIB vaccines, 50 of 1,455 (3.4%) participants experienced a serious adverse event (SAE). One SAE of seizure with apnea occurring on the day of vaccination with the first dose of the three vaccines was determined by the investigators as possibly related. Within 30 days following Dose 4, four of 418 (1.0%) participants who received DAPTACEL + ActHIB vaccines experienced a serious adverse event. None was assessed by the investigators as related to the study of vaccines.

Postmarketing Experience

The following events have been spontaneously reported during the post-approval use of ActHIB vaccine. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

  • Immune system disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
  • Nervous system disorders: Convulsions
  • General disorders and administration site conditions: Extensive limb swelling, peripheral edema, pruritus, rash (including generalized rash)

Read the entire FDA prescribing information for Acthib (Haemophilus b Conjugate Vaccine)

Related Resources for Acthib

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© Acthib Patient Information is supplied by Cerner Multum, Inc. and Acthib Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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