Medical Editor: John P. Cunha, DO, FACOEP
Flucelvax Quadrivalent (Influenza Vaccine) Suspension for Intramuscular Injection 2016-2017 Formula is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine, approved for use in persons 4 years of age and older. Common side effects of Flucelvax Quadrivalent include:
- injection site reactions (pain, redness, a hard lump, tenderness),
- headache,
- fatigue,
- muscle pain,
- chills,
- vomiting,
- diarrhea, and
- irritability and changes in eating habits (in children 4 to 6 years).
The dose of Flucelvax Quadrivalent for 4 through 8 years of age is one or two doses, 0.5 mL each, administered at least 4 weeks apart. The dose of Flucelvax Quadrivalent for 9 years of age and older is one 0.5 mL dose. Flucelvax Quadrivalent may interact with other drugs or vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. Tell your doctor if you are pregnant before receiving Flucelvax Quadrivalent; it is unknown if it would affect a fetus. It is unknown if Flucelvax Quadrivalent passes into breast milk. Consult your doctor before breastfeeding.
Our Flucelvax Quadrivalent (Influenza Vaccine) Suspension for Intramuscular Injection 2016-2017 Formula 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.
QUESTION
Which illness is known as a viral upper respiratory tract infection? See AnswerSIDE EFFECTS
Clinical Trials Experience
The most common ( ≥ 10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%) headache (18.7%), fatigue (17.8%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).
The most common ( ≥ 10%) local and systemic reactions in adults ≥ 65 years of age were injection site pain (21.6%), and injection site erythema (11.9%). The most common ( ≥ 10%) local and systemic reactions in children 4 to < 6 years of age after first dose of vaccine were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%) and change in eating habits (10%).
The most common ( ≥ 10%) local and systemic reactions in children 6 through 8 years of age after first dose of vaccine were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%) and myalgia (12%).
The most common ( ≥ 10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%), myalgia (16%), and injection site induration (15%).
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a vaccine cannot be directly compared to rates in clinical studies of another vaccine, and may not reflect rates observed in clinical practice.
Adults 18 Years Of Age And Older
The safety of FLUCELVAX QUADRIVALENT in adults was evaluated in a randomized, double-blind, controlled study conducted in the US (Study 1). The safety population included a total of 2680 adults 18 years of age and older; 1340 adults 18 through 64 years of age and 1340 adults 65 years of age and older.
In this study, subjects received FLUCELVAX QUADRIVALENT or one of the two formulations of comparator trivalent influenza vaccine (TIV1c and TIV2c) (FLUCELVAX QUADRIVALENT (n=1335), TIV1c, n=676 or TIV2c n= 669). The mean age of subjects who received FLUCELVAX QUADRIVALENT was 57.4 years of age; 54.8% of subjects were female and 75.6% were Caucasian, 13.4% were Black, 9.1% were Hispanics, 0.7% were American Indian and 0.3%, 0.1% and 0.7% were Asian, Native Hawaiian and others, respectively. The safety data observed are summarized in Table 2.
In this study, solicited local injection site and systemic adverse reactions were collected from subjects who completed a symptom diary card for 7 days following vaccination.
Solicited adverse reactions for FLUCELVAX QUADRIVALENT and comparator are summarized in Table 2.
Table 2: Incidence of Solicited Adverse Reactions in
the Safety Population1 Reported Within 7 Days of Vaccination (Study 1)
| 18 through 64 years of age | ≥ 65 years of age | |||||
| Percentages (%)2 | ||||||
| FLUCELVAX | Trivalent Influenza Vaccine | FLU- CELVAX | Trivalent Influenza Vaccine | |||
| VALENT N=663 |
TIVIc N=330 |
TIV2c N=327 |
RIVA- LENT N=656 | TIV1c N=340 |
TIV2c N=336 |
|
| Local Adverse Reactions | ||||||
| Injection site induration | 11.6 (0) | 9.7 (0.3) | 10.4 (0) | 8.7 (0) | 6.8 (0) | 7.7(0) |
| Injection site erythema | 13.4 (0) | 13.3 (0) | 10.1 (0) | 11.9 (0) | 10.6 (0) | 10.4 (0) |
| Injection site ecchymosis | 3.8 (0) | 3.3 (0.3) | 5.2 (0) | 4.7 (0) | 4.4 (0) | 5.4 (0) |
| Injection site pain | 45.4 (0.5) | 37.0 (0.3) | 40.7 (0) | 21.6 (0) | 18.8 (0) | 18.5 (0) |
| Systemic Adverse Reactions | ||||||
| Chills | 6.2 (0.2) | 6.4 (0.6) | 6.4 (0) | 4.4 (0.3) | 4.1 (0.3) | 4.5 (0.6) |
| Nausea | 9.7 (0.3) | 7.3 (0.9) | 8.9 (1.2) | 3.8 (0.2) | 4.1 (0) | 4.2 (0.3) |
| Myalgia | 15.4 (0.8) | 14.5 (0.9) | 15.0 (1.2) | 8.2 (0.2) | 9.4 (0.3) | 8.3 (0.6) |
| Arthralgia | 8.1 (0.5) | 8.2 (0) | 9.5 (0.9) | 5.5 (0.5) | 5.0 (0.3) | 6.8 (0.9) |
| Headache | 18.7 (0.9) | 18.5 (0.9) | 18.7 (0.6) | 9.3 (0.3) | 8.5 (0.6) | 8.3 (0.6) |
| Fatigue | 17.8 (0.6) | 22.1 (0.3) | 15.6 (1.5) | 9.1 (0.8) | 10.6 (0.3) | 8.9 (0.6) |
| Vomiting | 2.6 (0) | 1.5 (0.3) | 0.9 (0) | 0.9 (0.2) | 0.3 (0) | 0.6 (0) |
| Diarrhea | 7.4 (0.6) | 7.6 (0) | 7.6 (0.6) | 4.3 (0.5) | 5.0 (0.9) | 5.1 (0.3) |
| Loss of appetite | 8.3 (0.3) | 8.5 (0.3) | 8.3 (0.9) | 4.0 (0.2) | 5.0 (0) | 3.6 (0.3) |
| Fever: ≥ 38.0 °C( ≥ 40.0 °C) | 0.8 (0) | 0.6 (0) | 0.3 (0) | 0.3 (0) | 0.9 (0) | 0.6 (0) |
| 1Safety population: all subjects in the exposed
population who provided post-vaccination safety data 2Percentage of severe adverse reactions are presented in parenthesis Study 1: NCT01992094 |
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Unsolicited adverse events were collected for 21 days after vaccination. In adults 18 years of age and older, unsolicited adverse events were reported in 16.1% of subjects who received FLUCELVAX QUADRIVALENT, within 21 days after vaccination.
In adults 18 years of age and older, serious adverse events (SAEs) were collected throughout the study duration (until 6 months after vaccination) and were reported by 3.9%, of the subjects who received FLUCELVAX QUADRIVALENT. None of the SAEs were assessed as being related to study vaccine.
Children And Adolescents 4 Through 17 Years Of Age
The safety of FLUCELVAX QUADRIVALENT in children was evaluated in a randomized, double-blind, controlled study conducted in the US (Study 2). The safety population included a total of 2332 children 4 through 17 years of age; 1161 children 4 through 8 years of age and 1171 children 9 through 17 years of age.
In this study, subjects received FLUCELVAX QUADRIVALENT or one of the two formulations of comparator trivalent influenza vaccine (FLUCELVAX QUADRIVALENT n=1159, TIV1c, n=593 or TIV2c n= 580). Children 9 through 17 years of age received a single dose of FLUCELVAX QUADRIVALENT or comparator vaccine. Children 4 through 8 years of age received one or two doses (separated by 4 weeks) of FLUCELVAX QUADRIVALENT or comparator vaccine based on determination of the subject’s prior influenza vaccination history. The mean age of subjects who received FLUCELVAX QUADRIVALENT was 9.6 years of age; 48% of subjects were female and 53% were Caucasian.
The safety data observed are summarized in Table 3 and Table 4. In this study, solicited local injection site and systemic adverse reactions were collected from subjects who completed a symptom diary card for 7 days following vaccination.
Solicited adverse reactions for FLUCELVAX QUADRIVALENT and comparator are summarized in Table 3 and Table 4.
Table 3: Incidence of Solicited Adverse Reactions in
the Safety Population1 (4 through 5 years of age) Reported Within 7 Days of the
First dose of Vaccination (Study 2)
| Children 4 through 5 years | |||
| Percentages (%)2 | |||
| FLUCELVAX QUADRIVALENT N=182 | Trivalent Influenza Vaccine | ||
| TIV1c N=91 |
TIV2c N=93 |
||
| Local Adverse Reactions | |||
| Injection site induration | 13 (1) | 20 (2) | 13 (0) |
| Injection site erythema | 18 (1) | 23 (1) | 17 (0) |
| Injection site ecchymosis | 9 (0) | 11 (0) | 8 (0) |
| Injection site tenderness | 46 (1) | 45 (1) | 43 (0) |
| Systemic Adverse Reactions | |||
| Change in eating habits | 10 (1) | 7 | 6 |
| Sleepiness | 19 (1) | 12 (3) | 10 (0) |
| Irritability | 16 (2) | 10 (2) | 10 (1) |
| Chills | 5 (1) | 2 (0) | 1 (0) |
| Vomiting | 4 (0) | 2 (0) | 2 (0) |
| Diarrhea | 4 (0) | 2 (0) | 2 (0) |
| Fever: > 38.0 °C ( > 40.0 °C) | 4 (0) | 4 (0) | 3 (0) |
| 1Safety population: all subjects in the
exposed population who provided post-vaccination safety data. 2Percentage of subjects with severe adverse reactions are presented in parenthesis. Study 2: NCT01992107 |
|||
Table 4: Incidence of Solicited Adverse Reactions in
the Safety Population1 (Children 6 through 17 years of age) Reported Within 7
Days of Vaccination (Study 2)
| Children 6 through 8 years (after first dose) | Children 9 through 17 years | ||||||
| Percentages (%)2 | |||||||
| FLU- CELVAX QUADRI- VALENT N=371-372 |
Trivalent Influenza vaccine | FLU- CELVAX QUADRI- VALENT N=579 |
Trivalent Influenza Vaccine | ||||
| TIVIc N=185 |
TIV2c N=186 |
TIV1c N=294 |
TIV2c N=281-282 |
||||
| Local Adverse Reactions | |||||||
| Injection site induration | 16 (0) | 19 (1) | 13 (0) | 15 (0) | 15 (0) | 13 ( < 1) | |
| Injection site erythema | 22 (0) | 23 (1) | 20 (0) | 19 ( < 1) | 17 (0) | 15 ( < 1) | |
| Injection site ecchymosis | 9 (0) | 9 (0) | 8 (0) | 4 (0) | 5 (0) | 5 (0) | |
| Injection site pain | 54 (1) | 57 (1) | 58 (2) | 58 (1) | 51 ( < 1) | 50 (0) | |
| Systemic Adverse Events | |||||||
| Chills | 4 (1) | 3 (0) | 4 (0) | 7 (0) | 6 (1) | 4 (1) | |
| Nausea | 8 (1) | 5 (0) | 5 (1) | 9 ( < 1) | 8 (1) | 7 (1) | |
| Myalgia | 12 (1) | 14 (0) | 10 (0) | 16 ( < 1) | 17 ( < 1) | 15 ( < 1) | |
| Arthralgia | 4 (0) | 5 (0) | 4 (0) | 6 (0) | 6 (0) | 8 ( < 1) | |
| Headache | 14 (1) | 13 (0) | 12 (0) | 22 (1) | 23 (2) | 18 (1) | |
| Fatigue | 13 (2) | 14 (0) | 18 (0) | 18 ( < 1) | 16 (1) | 16 ( < 1) | |
| Vomiting | 3 (1) | 3 (0) | 3 (0) | 2 (0) | 1 (0) | 2 (0) | |
| Diarrhea | 3 ( < 1) | 6 (1) | 5 (0) | 4 (0) | 4 (0) | 3 ( < 1) | |
| Loss of appetite | 9 ( < 1) | 5 (0) | 8 (1) | 9 (0) | 9 ( < 1) | 9 (0) | |
| Fever: ≥ 38.0 °C ( ≥ 40.0 °C) | 4 (0) | 3 (0) | 2 (0) | 1 ( < 1) | 3 (0) | 1 (0) | |
| 1Safety population: all subjects in the
exposed population who provided post-vaccination safety data. 2Percentage of subjects with severe adverse reactions are presented in parenthesis. Study 2: NCT 01992107 |
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In children who received a second dose of FLUCELVAX QUADRIVALENT, TIV1c, or TIV2c, the incidence of adverse reactions following the second dose of vaccine were similar to those observed with the first dose. Unsolicited adverse events were collected for 21 days after last vaccination. In children 4 through 17 years of age, unsolicited adverse events were reported in 24.3 of subjects who received FLUCELVAX QUADRIVALENT, within 3 weeks after last vaccination.
In children 4 through 17 years of age, serious adverse events (SAEs) were collected throughout the study duration (until 6 months after last vaccination) and were reported by 0.5%, of the subjects who received FLUCELVAX QUADRIVALENT. None of the SAEs were assessed as being related to study vaccine.
Postmarketing Experience
The safety experience with FLUCELVAX (trivalent influenza vaccine) is relevant to FLUCELVAX QUADRIVALENT, because both vaccines are manufactured using the same process and have overlapping compositions.
The following additional adverse events have been identified during postapproval use of FLUCELVAX. 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 the vaccine.
Immune system disorders: Anaphylactic reaction, angioedema.
Skin and subcutaneous tissue disorders: Generalized skin reactions including pruritus, urticaria or non-specific rash.
Nervous systems disorders: Syncope, Presyncope
General disorders and administration site conditions: Extensive swelling of injected limb.
Read the entire FDA prescribing information for Flucelvax Quadrivalent 2016-2017 Formula (Influenza Vaccine)
SLIDESHOW
Natural Remedies for Cold and Flu See Slideshow© Flucelvax Quadrivalent 2016-2017 Formula Patient Information is supplied by Cerner Multum, Inc. and Flucelvax Quadrivalent 2016-2017 Formula Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.